Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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SET OF 10 ANCHOR BOLTS, LENGTH 25MM, ACCESSORY OF MICRODEEP DEPTH ELECTRODE
DIXI MEDICAL
ANCHOR BOLT
In Commercial Distribution

  • 03664539000671 ()
  • 03664539003290 ()

  • Length: 25 Millimeter
ACS-025SMS-10

  • Depth electrode
microTargeting™ Frame Single Tungsten 6X Non Sterile
FHC, INC.
34325Z-00793
In Commercial Distribution

  • 10873263007935 ()
  • 00873263007938 ()

  • Length: 263.4 Millimeter
  • Outer Diameter: 0.77 Millimeter
  • Length: 3 Millimeter
  • Length: 271.4 Millimeter
  • Impedance: Megaohms
34325Z

  • Depth electrode
microTargeting D.ZAP(L) Differential Electrode 5x, Sterile, Single, T=30 for use with Frame and STar or MT Drive
FHC, INC.
FC2002-00750
In Commercial Distribution

  • 10873263007508 ()
  • 00873263007501 ()

  • Length: 10 Millimeter
  • Impedance: Megaohms
  • Length: 271.4 Millimeter
  • Length: 256.4 Millimeter
  • Outer Diameter: 0.77 Millimeter
FC2002

  • Depth electrode
microTargeting Electrode 5x, non-sterile, Single, 1 Meg, T=30 for use with Frame, STar or MT Drive
FHC, INC.
FC1002-00747
In Commercial Distribution

  • 10873263007478 ()
  • 00873263007471 ()

  • Outer Diameter: 0.77 Millimeter
  • Length: 10 Millimeter
  • Length: 256.4 Millimeter
  • Impedance: Megaohms
  • Length: 271.4 Millimeter
FC1002

  • Depth electrode
microTargeting Differential Electrode 5x, Sterile, Single, 1 Meg, T=30 for use with frame, STar or MT Drive
FHC, INC.
34680-00746
In Commercial Distribution

  • 10873263007461 ()
  • 00873263007464 ()

  • Length: 256.4 Millimeter
  • Impedance: Megaohms
  • Length: 271.4 Millimeter
  • Outer Diameter: 0.77 Millimeter
  • Length: 10 Millimeter
34680

  • Depth electrode
microTargeting(TM) Electrode, differential, tungsten, nonsterile
FHC, INC.
MTDWBN(BP)(BP8)-00582
In Commercial Distribution

  • 10873263005825 ()
  • 00873263005828 ()

  • Length: 3 Millimeter
  • Outer Diameter: 0.77 Millimeter
  • Length: 271.4 Millimeter
  • Length: 263.4 Millimeter
  • Impedance: Megaohms
MTDWBN(BP)(BP8)

  • Depth electrode
microTargeting(TM) Electrode, non-sterile, single, T=30, for use with Frame and STar or MT Drive
FHC, INC.
34620R-00571
In Commercial Distribution

  • 10873263005719 ()
  • 00873263005712 ()

  • Length: 256.4 Millimeter
  • Length: 10 Millimeter
  • Length: 271.4 Millimeter
  • Outer Diameter: 0.77 Millimeter
  • Impedance: Megaohms
34620R

  • Depth electrode
microTargeting(TM) Electrode, differential, tungsten ground tip, nonsterile
FHC, INC.
MTDWXN(BS)(OC3)-00536
In Commercial Distribution

  • 10873263005368 ()
  • 00873263005361 ()

  • Length: 1 Millimeter
  • Length: 293 Millimeter
  • Outer Diameter: 0.77 Millimeter
  • Length: 286 Millimeter
MTDWXN(BS)(OC3)

  • Depth electrode
microTargeting(TM) Electrode, differential, tungsten, D.ZAP(L), nonsterile
FHC, INC.
MTDWLN(BS)(FM2)-00534
In Commercial Distribution

  • 10873263005344 ()
  • 00873263005347 ()

  • Outer Diameter: 0.77 Millimeter
  • Length: 2 Millimeter
  • Length: 93 Millimeter
  • Length: 100 Millimeter
  • Impedance: Megaohms
MTDWLN(BS)(FM2)

  • Depth electrode
microTargeting(TM) Electrode, differential, tungsten, DZAP(Z), nonsterile
FHC, INC.
MTDWZN(BP)(BP8)-00439
Not in Commercial Distribution

  • 10873263004392 ()
  • 00873263004395 ()

  • Impedance: Megaohms
  • Outer Diameter: 0.77 Millimeter
  • Length: 263.4 Millimeter
  • Length: 271.4 Millimeter
  • Length: 3 Millimeter
MTDWZN(BP)(BP8)

  • Depth electrode
microTargeting(TM) Electrode, differential, tungsten, nonsterile
FHC, INC.
MTDWXN(BS)(OC2)-00409
In Commercial Distribution

  • 10873263004095 ()
  • 00873263004098 ()

  • Length: 2 Millimeter
  • Outer Diameter: 0.77 Millimeter
  • Length: 293 Millimeter
  • Length: 286 Millimeter
MTDWXN(BS)(OC2)

  • Depth electrode
microTargeting(TM) Electrode, differential, tungsten, nonsterile
FHC, INC.
MTDWXN(BP)(BP7)-00406
In Commercial Distribution

  • 10873263004064 ()
  • 00873263004067 ()

  • Outer Diameter: 0.77 Millimeter
  • Length: 10 Millimeter
  • Length: 256.4 Millimeter
  • Length: 271.4 Millimeter
MTDWXN(BP)(BP7)

  • Depth electrode
microTargeting(TM) Electrode, differential, tungsten, D.ZAP(L), nonsterile
FHC, INC.
MTDWLN(BP)(BP8)-00396
In Commercial Distribution

  • 10873263003968 ()
  • 00873263003961 ()

  • Length: 271.4 Millimeter
  • Length: 263.4 Millimeter
  • Impedance: Megaohms
  • Length: 3 Millimeter
  • Outer Diameter: 0.77 Millimeter
MTDWLN(BP)(BP8)

  • Depth electrode
microTargeting(TM) Electrode, differential, tungsten, nonsterile
FHC, INC.
MTDWBN(LS)(LS3)-00386
In Commercial Distribution

  • 10873263003869 ()
  • 00873263003862 ()

  • Length: 291.5 Millimeter
  • Length: 273.5 Millimeter
  • Outer Diameter: 0.77 Millimeter
  • Impedance: Megaohms
  • Length: 10 Millimeter
MTDWBN(LS)(LS3)

  • Depth electrode
microTargeting(TM) Electrode, differential, tungsten, nonsterile
FHC, INC.
MTDWBN(BP)(BP7)-00384
In Commercial Distribution

  • 10873263003845 ()
  • 00873263003848 ()

  • Length: 256.4 Millimeter
  • Outer Diameter: 0.77 Millimeter
  • Impedance: Megaohms
  • Length: 271.4 Millimeter
  • Length: 10 Millimeter
MTDWBN(BP)(BP7)

  • Depth electrode
microTargeting(TM) Electrode, differential, tungsten, non sterile
FHC, INC.
MTDWBN(BP)(BP6)-00382
In Commercial Distribution

  • 10873263003821 ()
  • 00873263003824 ()

  • Length: 227 Millimeter
  • Length: 277 Millimeter
  • Impedance: Megaohms
  • Outer Diameter: 0.77 Millimeter
  • Length: 10 Millimeter
MTDWBN(BP)(BP6)

  • Depth electrode
microTargeting(TM) Electrode, differential, tungsten, nonsterile
FHC, INC.
MTDWBN(BP)(BP5)-00380
In Commercial Distribution

  • 10873263003807 ()
  • 00873263003800 ()

  • Length: 215 Millimeter
  • Length: 10 Millimeter
  • Impedance: Megaohms
  • Length: 265 Millimeter
  • Outer Diameter: 0.77 Millimeter
MTDWBN(BP)(BP5)

  • Depth electrode
microTargeting(TM) Electrode, non-sterile, single, D.ZAP(Z) T=30, for use with Frame and STar or MT Drive
FHC, INC.
34625Z-00249
In Commercial Distribution

  • 10873263002497 ()
  • 00873263002490 ()

  • Outer Diameter: 0.77 Millimeter
  • Length: 256.4 Millimeter
  • Length: 271.4 Millimeter
  • Length: 10 Millimeter
  • Impedance: Megaohms
34625Z

  • Depth electrode
microTargeting(TM) Electrode, non-sterile, single, DZAP(L) T=30, for use with Frame and STar or MT Drive
FHC, INC.
34625L-00248
In Commercial Distribution

  • 10873263002480 ()
  • 00873263002483 ()

  • Length: 256.4 Millimeter
  • Length: 10 Millimeter
  • Outer Diameter: 0.77 Millimeter
  • Length: 271.4 Millimeter
  • Impedance: Megaohms
34625L

  • Depth electrode
microTargeting Electrode 6x, non-sterile, Single, 1 Meg, T=30 for use with Frame, STar or MT Drive
FHC, INC.
FC1002-00135
Not in Commercial Distribution

  • 10873263001353 ()
  • 00873263001356 ()

  • Length: 271.4 Millimeter
  • Impedance: Megaohms
  • Outer Diameter: 0.77 Millimeter
  • Length: 256.4 Millimeter
  • Length: 10 Millimeter
FC1002

  • Depth electrode
microTargeting D.ZAP(L) Differential Electrode 5x, Sterile, Single, T=30 for use with Frame and STar or MT Drive
FHC, INC.
FC2002-00127
Not in Commercial Distribution

  • 10873263001278 ()
  • 00873263001271 ()

  • Outer Diameter: 0.77 Millimeter
  • Impedance: Megaohms
  • Length: 10 Millimeter
  • Length: 271.4 Millimeter
  • Length: 256.4 Millimeter
FC2002

  • Depth electrode
microTargeting Differential Electrode 5x, Sterile, Single, 1 Meg, T=30 for use with frame, STar or MT Drive
FHC, INC.
34680-00125
Not in Commercial Distribution

  • 10873263001254 ()
  • 00873263001257 ()

  • Impedance: Megaohms
  • Length: 256.4 Millimeter
  • Length: 271.4 Millimeter
  • Length: 10 Millimeter
  • Outer Diameter: 0.77 Millimeter
34680

  • Depth electrode
microTargeting™ Frame Single Tungsten 5X Sterile
FHC, INC.
34385Z-00794
In Commercial Distribution

  • 10873263007942 ()
  • 00873263007945 ()

  • Impedance: Megaohms
  • Outer Diameter: 0.77 Millimeter
  • Length: 263.4 Millimeter
  • Length: 3 Millimeter
  • Length: 271.4 Millimeter
34385Z

  • Depth electrode
microTargeting(TM) Electrode, differential, tungsten, D.ZAP(L), sterile
FHC, INC.
MTDWLP(BS)(FM2)-00538
In Commercial Distribution

  • 10873263005382 ()
  • 00873263005385 ()

  • Length: 2 Millimeter
  • Length: 100 Millimeter
  • Impedance: Megaohms
  • Outer Diameter: 0.77 Millimeter
  • Length: 93 Millimeter
MTDWLP(BS)(FM2)

  • Depth electrode
microTargeting(TM) Electrode, differential, tungsten, DZAP(Z), sterile
FHC, INC.
MTDWZP(BP)(B10)-00456
In Commercial Distribution

  • 10873263004569 ()
  • 00873263004562 ()

  • Length: 261.4 Millimeter
  • Length: 271.4 Millimeter
  • Impedance: Megaohms
  • Length: 5 Millimeter
  • Outer Diameter: 0.77 Millimeter
MTDWZP(BP)(B10)

  • Depth electrode
microTargeting Electrode, differential, tungsten, DZAP(Z), sterile
FHC, INC.
MTDWZP(BP)(BP5)-00454
In Commercial Distribution

  • 10873263004545 ()
  • 00873263004548 ()

  • Impedance: Megaohms
  • Length: 10 Millimeter
  • Length: 265 Millimeter
  • Length: 215 Millimeter
  • Outer Diameter: 0.77 Millimeter
MTDWZP(BP)(BP5)

  • Depth electrode
microTargeting(TM) Electrode, differential, tungsten, sterile, DZAP(L)
FHC, INC.
MTDWLP(BP)(BP8)-00400
In Commercial Distribution

  • 10873263004002 ()
  • 00873263004005 ()

  • Length: 271.4 Millimeter
  • Outer Diameter: 0.77 Millimeter
  • Length: 263.4 Millimeter
  • Impedance: Megaohms
  • Length: 3 Millimeter
MTDWLP(BP)(BP8)

  • Depth electrode
microTargeting(TM) Electrode, differential, tungsten, sterile
FHC, INC.
MTDWBP(LS)(LS3)-00388
In Commercial Distribution

  • 10873263003883 ()
  • 00873263003886 ()

  • Impedance: Megaohms
  • Length: 10 Millimeter
  • Outer Diameter: 0.77 Millimeter
  • Length: 291.5 Millimeter
  • Length: 273.5 Millimeter
MTDWBP(LS)(LS3)

  • Depth electrode
microTargeting(TM) Electrode, shielded, tungsten, DZAP(L), sterile
FHC, INC.
MTSWLP(JN)(JN1)-00492
In Commercial Distribution

  • 10873263004927 ()
  • 00873263004920 ()

  • Impedance: Megaohms
  • Length: 251.4 Millimeter
  • Length: 278.4 Millimeter
  • Length: 25 Millimeter
  • Outer Diameter: 0.77 Millimeter
MTSWLP(JN)(JN1)

  • Depth electrode
microTargeting(TM) Electrode, shielded, tungsten, sterile
FHC, INC.
MTSWBP(JN)(JN2)-00490
In Commercial Distribution

  • 10873263004903 ()
  • 00873263004906 ()

  • Impedance: Megaohms
  • Outer Diameter: 0.77 Millimeter
  • Length: 16 Millimeter
  • Length: 288.4 Millimeter
  • Length: 270.4 Millimeter
MTSWBP(JN)(JN2)

  • Depth electrode
microTargeting(TM) Electrode, differential, tungsten, DZAP(Z), sterile
FHC, INC.
MTDWZP(BP)(BP8)-00459
In Commercial Distribution

  • 10873263004590 ()
  • 00873263004593 ()

  • Length: 3 Millimeter
  • Impedance: Megaohms
  • Length: 271.4 Millimeter
  • Length: 263.4 Millimeter
  • Outer Diameter: 0.77 Millimeter
MTDWZP(BP)(BP8)

  • Depth electrode
microTargeting(TM) Electrode, differential, tungsten, D.ZAP(L), sterile
FHC, INC.
MTDWLP(BP)(BP6)-00398
In Commercial Distribution

  • 10873263003982 ()
  • 00873263003985 ()

  • Impedance: Megaohms
  • Length: 10 Millimeter
  • Outer Diameter: 0.77 Millimeter
  • Length: 277 Millimeter
  • Length: 227 Millimeter
MTDWLP(BP)(BP6)

  • Depth electrode
microTargeting(TM) Electrode, 1x, sterile, single, D.ZAP(Z), T=30 for use with Frame and STar or MT Drive
FHC, INC.
34685Z-00254
In Commercial Distribution

  • 10873263002541 ()
  • 00873263002544 ()

  • Length: 256.4 Millimeter
  • Impedance: Megaohms
  • Length: 271.4 Millimeter
  • Length: 10 Millimeter
  • Outer Diameter: 0.77 Millimeter
34685Z

  • Depth electrode
microTargeting(TM) Electrode, sterile, single, D.ZAP(L), T=30 for use with Frame and STar or MT Drive
FHC, INC.
34685L-00252
In Commercial Distribution

  • 10873263002527 ()
  • 00873263002520 ()

  • Length: 256.4 Millimeter
  • Length: 10 Millimeter
  • Outer Diameter: 0.77 Millimeter
  • Impedance: Megaohms
  • Length: 271.4 Millimeter
34685L

  • Depth electrode
microTargeting(TM) Electrode, differential, sterile, single, 1 Meg for use with Frame and STar or MT Drive
FHC, INC.
34680R-00250
In Commercial Distribution

  • 10873263002503 ()
  • 00873263002506 ()

  • Impedance: Megaohms
  • Length: 10 Millimeter
  • Outer Diameter: 0.77 Millimeter
  • Length: 256.4 Millimeter
  • Length: 271.4 Millimeter
34680R

  • Depth electrode
16mm x 25mm Cage; The Asfora Bullet Cage® is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) and instability in the lumbar spine at one or two contiguous levels from L2 to S1. DDD for lumbar systems is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). The ABC cage devices are used with autogenous bone graft. Patients should be skeletally mature and have had at least six (6) months of non-operative treatment prior to implant. When implanted via a posterior (PLIF, TLIF) approach, this device should be used with supplemental fixation.
MEDICAL DESIGNS LLC
11-9902-FD8
In Commercial Distribution

  • 1199028 ()
  • M364119902FD80 ()

  • Outer Diameter: 16 Millimeter
  • Length: 25 Millimeter


  • Metallic spinal interbody fusion cage
14mm x 25mm Cage; The Asfora Bullet Cage® is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) and instability in the lumbar spine at one or two contiguous levels from L2 to S1. DDD for lumbar systems is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). The ABC cage devices are used with autogenous bone graft. Patients should be skeletally mature and have had at least six (6) months of non-operative treatment prior to implant. When implanted via a posterior (PLIF, TLIF) approach, this device should be used with supplemental fixation.
MEDICAL DESIGNS LLC
11-9902-FD6
In Commercial Distribution

  • 1199026 ()
  • M364119902FD60 ()

  • Outer Diameter: 14 Millimeter
  • Length: 25 Millimeter


  • Metallic spinal interbody fusion cage
12mm x 25mm Cage; The Asfora Bullet Cage® is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) and instability in the lumbar spine at one or two contiguous levels from L2 to S1. DDD for lumbar systems is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). The ABC cage devices are used with autogenous bone graft. Patients should be skeletally mature and have had at least six (6) months of non-operative treatment prior to implant. When implanted via a posterior (PLIF, TLIF) approach, this device should be used with supplemental fixation.
MEDICAL DESIGNS LLC
11-9902-FD4
In Commercial Distribution

  • 1199024 ()
  • M364119902FD40 ()

  • Outer Diameter: 12 Millimeter
  • Length: 25 Millimeter


  • Metallic spinal interbody fusion cage
10mm x 25mm Cage; The Asfora Bullet Cage® is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) and instability in the lumbar spine at one or two contiguous levels from L2 to S1. DDD for lumbar systems is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). The ABC cage devices are used with autogenous bone graft. Patients should be skeletally mature and have had at least six (6) months of non-operative treatment prior to implant. When implanted via a posterior (PLIF, TLIF) approach, this device should be used with supplemental fixation
MEDICAL DESIGNS LLC
11-9902-FD2
In Commercial Distribution

  • 1199022 ()
  • M364119902FD20 ()

  • Outer Diameter: 10 Millimeter
  • Length: 25 Millimeter


  • Metallic spinal interbody fusion cage
18mm x 25mm Cage; The Asfora Bullet Cage® is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) and instability in the lumbar spine at one or two contiguous levels from L2 to S1. DDD for lumbar systems is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). The ABC cage devices are used with autogenous bone graft. Patients should be skeletally mature and have had at least six (6) months of non-operative treatment prior to implant. When implanted via a posterior (PLIF, TLIF) approach, this device should be used with supplemental fixation.
MEDICAL DESIGNS LLC
11-9902-FD10
In Commercial Distribution

  • 11990210 ()
  • M364119902FD100 ()

  • Outer Diameter: 18 Millimeter
  • Length: 25 Millimeter


  • Metallic spinal interbody fusion cage
PS, MIS-Tower Reduction, Cannulated Dual Lead 8.5X25mm. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
PDR-850-025
In Commercial Distribution

  • 00814008029419 ()

  • Length: 25 Millimeter
  • Outer Diameter: 8.5 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
PS, MIS-Tower Reduction, Cannulated Dual Lead 7.5X25mm. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
PDR-750-025
In Commercial Distribution

  • 00814008029334 ()

  • Length: 25 Millimeter
  • Outer Diameter: 7.5 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
PS, MIS-Tower Reduction, Cannulated Dual Lead 6.5X25mm. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
PDR-650-025
In Commercial Distribution

  • 00814008029259 ()

  • Length: 25 Millimeter
  • Outer Diameter: 6.5 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
PS, MIS-Tower Reduction, Cannulated Dual Lead 5.5X25mm. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
PDR-550-025
In Commercial Distribution

  • 00814008029174 ()

  • Length: 25 Millimeter
  • Outer Diameter: 5.5 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
PS, MIS-Tower Reduction, Cannulated Dual Lead 4.75X25mm. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
PDR-475-025
In Commercial Distribution

  • 00814008029099 ()

  • Length: 25 Millimeter
  • Outer Diameter: 4.75 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
PS, MIS-Tower Reduction, Cannulated Cortical Cancellous 8.5X25mm. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
PDCR-850-025
In Commercial Distribution

  • 00814008028917 ()

  • Length: 25 Millimeter
  • Outer Diameter: 8.5 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
PS, MIS-Tower Reduction, Cannulated Cortical Cancellous 7.5X25mm. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
PDCR-750-025
In Commercial Distribution

  • 00814008028832 ()

  • Length: 25 Millimeter
  • Outer Diameter: 7.5 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
PS, MIS-Tower Reduction, Cannulated Cortical Cancellous 6.5X25mm. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
PDCR-650-025
In Commercial Distribution

  • 00814008028757 ()

  • Length: 25 Millimeter
  • Outer Diameter: 6.5 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
PS, MIS-Tower Reduction, Cannulated Cortical Cancellous 5.5X25mm. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
PDCR-550-025
In Commercial Distribution

  • 00814008028672 ()

  • Length: 25 Millimeter
  • Outer Diameter: 5.5 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
PS, MIS-Tower Reduction, Cannulated Cortical Cancellous 4.75X25mm. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
PDCR-475-025
In Commercial Distribution

  • 00814008028597 ()

  • Length: 25 Millimeter
  • Outer Diameter: 4.75 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
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