Company Name Brand Name GMDN Term 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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primaLOK FF 25mm Implant Assembly, Sterile The Wenzel Spine primaLOK FF Facet Fixation System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints. It is intended for use with or without bone graft, at a single or multiple levels from L1 to S1 inclusive. It is indicated for the posterior surgical treatment of any or all of the following: degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the facets with instability, trauma (i.e., fracture or dislocation), spondylolisthesis, spondylolysis, and pseudoarthrosis and failed fusions which are symptomatic or which may cause secondary instability or deformity. For transfacet fixation, the screws are inserted through the inferior articular process across the facet joint and into the pedicle. For translaminar facet fixation, the screws are inserted through the lateral aspect of the spinous process, through the lamina, through the inferior articular process, across the facet joint and into the pedicle.
WENZEL SPINE, INC.
800-1125-00
In Commercial Distribution

  • 00813210021952 ()

  • Length: 25 Millimeter


  • Orthopaedic bone screw, non-bioabsorbable, sterile
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, 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, 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, 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, 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, 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
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(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, differential, tungsten, DZAP(Z), nonsterile
FHC, INC.
MTDWZN(BP)(BP8)-00439
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.
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
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