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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No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1425
In Commercial Distribution

  • 09348215024079 ()


  • Coated femoral stem prosthesis, modular
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1325
In Commercial Distribution

  • 09348215024062 ()


  • Coated femoral stem prosthesis, modular
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1225
In Commercial Distribution

  • 09348215024055 ()


  • Coated femoral stem prosthesis, modular
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1125
In Commercial Distribution

  • 09348215024048 ()


  • Coated femoral stem prosthesis, modular
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1025
In Commercial Distribution

  • 09348215024031 ()


  • Coated femoral stem prosthesis, modular
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-0925
In Commercial Distribution

  • 09348215024024 ()


  • Coated femoral stem prosthesis, modular
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1806
In Commercial Distribution

  • 09348215024017 ()


  • Coated femoral stem prosthesis, modular
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1606
In Commercial Distribution

  • 09348215024000 ()


  • Coated femoral stem prosthesis, modular
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1506
In Commercial Distribution

  • 09348215023997 ()


  • Coated femoral stem prosthesis, modular
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1406
In Commercial Distribution

  • 09348215023980 ()


  • Coated femoral stem prosthesis, modular
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1306
In Commercial Distribution

  • 09348215023973 ()


  • Coated femoral stem prosthesis, modular
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1206
In Commercial Distribution

  • 09348215023966 ()


  • Coated femoral stem prosthesis, modular
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1106
In Commercial Distribution

  • 09348215023959 ()


  • Coated femoral stem prosthesis, modular
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1006
In Commercial Distribution

  • 09348215023942 ()


  • Coated femoral stem prosthesis, modular
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-0906
In Commercial Distribution

  • 09348215023935 ()


  • Coated femoral stem prosthesis, modular
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-0803
In Commercial Distribution

  • 09348215023836 ()


  • Coated femoral stem prosthesis, modular
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-0826
In Commercial Distribution

  • 09348215083564 ()


  • Coated femoral stem prosthesis, modular
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1826
In Commercial Distribution

  • 09348215024192 ()


  • Coated femoral stem prosthesis, modular
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1626
In Commercial Distribution

  • 09348215024185 ()


  • Coated femoral stem prosthesis, modular
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1526
In Commercial Distribution

  • 09348215024178 ()


  • Coated femoral stem prosthesis, modular
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1426
In Commercial Distribution

  • 09348215024161 ()


  • Coated femoral stem prosthesis, modular
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1326
In Commercial Distribution

  • 09348215024154 ()


  • Coated femoral stem prosthesis, modular
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1226
In Commercial Distribution

  • 09348215024147 ()


  • Coated femoral stem prosthesis, modular
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1126
In Commercial Distribution

  • 09348215024130 ()


  • Coated femoral stem prosthesis, modular
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1026
In Commercial Distribution

  • 09348215024123 ()


  • Coated femoral stem prosthesis, modular
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-0926
In Commercial Distribution

  • 09348215024116 ()


  • Coated femoral stem prosthesis, modular
18mm x 21mm 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-FD9
In Commercial Distribution

  • 1199029 ()
  • M364119902FD90 ()

  • Outer Diameter: 18 Millimeter
  • Length: 21 Millimeter


  • Metallic spinal interbody fusion cage
16mm x 21mm 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-FD7
In Commercial Distribution

  • M364119902FD70 ()


  • Metallic spinal interbody fusion cage
14mm x 21mm 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-FD5
In Commercial Distribution

  • 1199025 ()
  • M364119902FD50 ()

  • Outer Diameter: 14 Millimeter
  • Length: 21 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
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