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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17x14 Insert Comp Ti Fork Stop
AMEDICA CORPORATION
A
In Commercial Distribution

  • M555910025702 ()
91.002.5702

  • Internal spinal fixation procedure kit, single-use
16x12 Insert Comp Ti Fork Stop
AMEDICA CORPORATION
A
In Commercial Distribution

  • M555910025700 ()
91.002.5700

  • Internal spinal fixation procedure kit, single-use
Valeo C Starter 17x14 with Indicator Line
AMEDICA CORPORATION
A
In Commercial Distribution

  • M555910025014 ()
91.002.5014

  • Internal spinal fixation procedure kit, single-use
Cervical Final Driver
AMEDICA CORPORATION
A
In Commercial Distribution

  • M555910025005 ()
91.002.5005

  • Internal spinal fixation procedure kit, single-use
C Rasp 17x14, 5mm, 6 Deg Stop
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555910024107 ()
91.002.4107

  • Internal spinal fixation procedure kit, reusable
C Rasp 16x12, 5mm, 6 Deg Stop
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555910024106 ()
91.002.4106

  • Internal spinal fixation procedure kit, reusable
C Rasp 17x14, 5mm, 0 Deg Stop
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555910024007 ()
91.002.4007

  • Internal spinal fixation procedure kit, reusable
C Rasp 16x12, 5mm, 0 Deg Stop
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555910024006 ()
91.002.4006

  • Internal spinal fixation procedure kit, reusable
16x12 Valeo-C Packing Fixture
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555910024002 ()
91.002.4002

  • Orthopaedic implant impactor, reusable
Trial 17x14, 0°, 8mm
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555910023308 ()

  • Length: 17 Millimeter
  • Width: 14 Millimeter
  • Height: 8 Millimeter
91.002.3308

  • Spinal implant trial
Universal Drill Guide
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555910021002 ()
91.002.1002

  • Internal spinal fixation procedure kit, reusable
Taurus Pedicle Screw System- Headbody, Assembly, Standard
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555510000001 ()
51-0000-001

  • Spinal bone screw head/rod adaptor
Handle, Palm, Standard
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555509000003 ()
50-9000-003

  • Internal spinal fixation procedure kit, reusable
Counter-Torque
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555507000005 ()
50-7000-005

  • Internal spinal fixation procedure kit, reusable
Inserter, Set-Screw, Palm, T30
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555507000002 ()
50-7000-002

  • Surgical implant/trial-implant/sizer holder, reusable
Inserter, Set-Screw, Double Sided, T30
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555507000001 ()
50-7000-001

  • Surgical implant/trial-implant/sizer holder, reusable
Persuader, Tower
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555506000004 ()
50-6000-004

  • Internal spinal fixation procedure kit, reusable
Parallel Distractor
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555506000002 ()
50-6000-002

  • Orthopaedic surgical distractor, internal
Parallel Compressor
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555506000001 ()
50-6000-001

  • Internal spinal fixation procedure kit, reusable
Handle, T, Torque Limiting, 7Mm Hex, 80-In-Lb
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555505000028 ()
50-5000-028

  • Internal spinal fixation procedure kit, reusable
Handle, Axial, Ratcheting, Qtr In Sq
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555505000010 ()
50-5000-010

  • Internal spinal fixation procedure kit, reusable
Handle, T, Ratcheting, Qtr In Sq
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555505000009 ()
50-5000-009

  • Internal spinal fixation procedure kit, reusable
Handle, Axial, Ratcheting, Qtr In Sq
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555505000008 ()
50-5000-008

  • Internal spinal fixation procedure kit, reusable
Rod Rocker
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555504000007 ()
50-4000-007

  • Internal spinal fixation procedure kit, reusable
Rod Forceps, Long, 5.5mm
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555504000004 ()
50-4000-004

  • Surgical implant/trial-implant/sizer holder, reusable
Headbody Manipulator
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555503000006 ()
50-3000-006

  • Internal spinal fixation procedure kit, reusable
Head Inserter
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555503000005 ()
50-3000-005

  • Surgical implant/trial-implant/sizer holder, reusable
Screwdriver, Adjustment/ Removal, T25
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555503000004 ()
50-3000-004

  • Internal spinal fixation procedure kit, reusable
Screwdriver, Polyaxial, Reduction
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555503000003 ()
50-3000-003

  • Internal spinal fixation procedure kit, reusable
Screwdriver, Polyaxial, Standard
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555503000002 ()
50-3000-002

  • Internal spinal fixation procedure kit, reusable
Screwdriver, Headless Screw
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555503000001 ()
50-3000-001

  • Internal spinal fixation procedure kit, reusable
Tap, Double Lead, Cannulated, 8.5
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555502001085 ()
50-2001-085

  • Internal spinal fixation procedure kit, reusable
Tap, Double Lead, Cannulated, 7.5
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555502001075 ()
50-2001-075

  • Internal spinal fixation procedure kit, reusable
Tap, Double Lead, Cannulated, 6.5
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555502001065 ()
50-2001-065

  • Internal spinal fixation procedure kit, reusable
Tap, Double Lead, Cannulated, 5.5
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555502001055 ()
50-2001-055

  • Internal spinal fixation procedure kit, reusable
Tap, Double Lead, Cannulated, 4.5
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555502001045 ()
50-2001-045

  • Internal spinal fixation procedure kit, reusable
Awl, Cannulated
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555502001007 ()
50-2001-007

  • Internal spinal fixation procedure kit, reusable
Probe, Straight, Cannulated
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555502001004 ()
50-2001-004

  • Internal spinal fixation procedure kit, reusable
Tap, Double Lead, 8.5
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555502000085 ()
50-2000-085

  • Internal spinal fixation procedure kit, reusable
Tap, Double Lead, 7.5
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555502000075 ()
50-2000-075

  • Internal spinal fixation procedure kit, reusable
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