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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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Proficient® Posterior Cervical Spine System - 10840642124002

Cannulated Smooth-Shank Translational Screw, 3.8 mm × 24 mm
Spine Wave, Inc.
21-8481
In Commercial Distribution

  • 10840642124002 ()
21-8481

  • Spinal bone screw, non-bioabsorbable

Balteum - 08800039874946

Lumbar Plate Variable screw (Self-Tapping) 6.5 x 24
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08800039874946 ()
AL.VT.6524

  • Spinal fixation plate, non-bioabsorbable

Balteum - 08800039874625

Lumbar Plate Variable screw (Self-Tapping) 5.5 x 24
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08800039874625 ()
AL.VT.5524

  • Spinal fixation plate, non-bioabsorbable

Proficient™ Posterior Cervical Spine System - 10840642109863

Extended Tab Screw, 3.8 mm x 24 mm
Spine Wave, Inc.
11-8101
In Commercial Distribution

  • 10840642109863 ()
11-8101

  • Spinal bone screw, non-bioabsorbable

Proficient™ Posterior Cervical Spine System - 10840642110067

Extended Tab Screw, 4.6 mm x 24 mm
Spine Wave, Inc.
11-8147
In Commercial Distribution

  • 10840642110067 ()
11-8147

  • Spinal bone screw, non-bioabsorbable

Proficient™ Posterior Cervical Spine System - 10840642109993

Extended Tab Screw, 4.2 mm x 24 mm
Spine Wave, Inc.
11-8124
In Commercial Distribution

  • 10840642109993 ()
11-8124

  • Spinal bone screw, non-bioabsorbable

Fortis ACP - 08800039834483

Fixed Angle Selftapping Rounded Screw 4.5 X 24
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08800039834483 ()
TP.FTR.4524

  • Spinal fixation plate, non-bioabsorbable

Fortis ACP - 08800039834391

Fixed Angle Selftapping Rounded Screw 4.0 X 24
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08800039834391 ()
TP.FTR.4024

  • Spinal fixation plate, non-bioabsorbable

Fortis ACP - 08800039834308

Variable Angle Selftapping Rounded Screw 4.5 X 24
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08800039834308 ()
TP.VTR.4524

  • Spinal fixation plate, non-bioabsorbable

Fortis ACP - 08800039834216

Variable Angle Selftapping Rounded Screw 4.0 X 24
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08800039834216 ()
TP.VTR.4024

  • Spinal fixation plate, non-bioabsorbable
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