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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 - 10840642126181

Cannulated Extended-Tab Translational Screw, 3.8 mm × 20 mm
Spine Wave, Inc.
21-8628
In Commercial Distribution

  • 10840642126181 ()
21-8628

  • Spinal bone screw, non-bioabsorbable

Proficient® Posterior Cervical Spine System - 10840642125955

Extended-Tab Smooth-Shank Translational Screw, 4.2 mm × 20 mm
Spine Wave, Inc.
21-8605
In Commercial Distribution

  • 10840642125955 ()
21-8605

  • Spinal bone screw, non-bioabsorbable

Proficient® Posterior Cervical Spine System - 10840642124163

Cannulated Smooth-Shank Translational Screw, 4.2 mm × 20 mm
Spine Wave, Inc.
21-8515
In Commercial Distribution

  • 10840642124163 ()
21-8515

  • Spinal bone screw, non-bioabsorbable

Proficient® Posterior Cervical Spine System - 10840642123982

Cannulated Smooth-Shank Translational Screw, 3.8 mm × 20 mm
Spine Wave, Inc.
21-8479
In Commercial Distribution

  • 10840642123982 ()
21-8479

  • Spinal bone screw, non-bioabsorbable

GEN2 - 00840343713690

KNIFE HANDLE #4 HOLDS BLADES 20 THRU 25
SURGIX MEDICAL LLC
G2G14210
In Commercial Distribution

  • 00840343713690 ()

  • Length: 8.375 Inch
G2G14210

  • Scalpel handle, reusable

N/A - 08800043902956

Nail Locking Screw, Ø4.0mm Large Head 20 mm
TDM Co., Ltd.
540-20020
In Commercial Distribution

  • 08800043902956 ()
540-20020

  • Orthopaedic bone screw (non-sliding)

Proficient™ Posterior Cervical Spine System - 10840642113303

Extended Tab Screw, 5.5 mm x 20 mm
Spine Wave, Inc.
11-8168
In Commercial Distribution

  • 10840642113303 ()
11-8168

  • Spinal bone screw, non-bioabsorbable

Fortis ACP - 08800039834193

Variable Angle Selftapping Rounded Screw 4.0 X 20
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08800039834193 ()
TP.VTR.4020

  • Spinal fixation plate, non-bioabsorbable

Fortis ACP - 08800039834469

Fixed Angle Selftapping Rounded Screw 4.5 X 20
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08800039834469 ()
TP.FTR.4520

  • Spinal fixation plate, non-bioabsorbable

Fortis ACP - 08800039834377

Fixed Angle Selftapping Rounded Screw 4.0 X 20
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08800039834377 ()
TP.FTR.4020

  • Spinal fixation plate, non-bioabsorbable
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