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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Valeo TL Trial Full Size, 17mm
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555910013517 ()
91.001.3517

  • Spinal implant trial
Valeo TL Trial Full Size, 16mm
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555910013516 ()
91.001.3516

  • Spinal implant trial
Valeo TL Trial Full Size, 15mm
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555910013515 ()
91.001.3515

  • Spinal implant trial
Valeo TL Trial Full Size, 14mm
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555910013514 ()
91.001.3514

  • Spinal implant trial
Valeo TL Trial Full Size, 13mm
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555910013513 ()
91.001.3513

  • Spinal implant trial
Valeo TL Trial Full Size, 12mm
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555910013512 ()
91.001.3512

  • Spinal implant trial
Valeo TL Trial Full Size, 11mm
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555910013511 ()
91.001.3511

  • Spinal implant trial
Valeo TL Trial Full Size, 10mm
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555910013510 ()
91.001.3510

  • Spinal implant trial
Valeo TL Trial Full Size, 9mm
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555910013509 ()
91.001.3509

  • Spinal implant trial
Valeo TL Trial Full Size, 8mm
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555910013508 ()
91.001.3508

  • Spinal implant trial
Valeo TL Trial Full Size, 7mm
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555910013507 ()
91.001.3507

  • Spinal implant trial
Valeo TL Implant Trial, 17mm
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555910013317 ()
91.001.3317

  • Spinal implant trial
Valeo TL Implant Trial, 15mm
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555910013315 ()
91.001.3315

  • Spinal implant trial
Valeo TL Implant Trial, 13mm
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555910013313 ()
91.001.3313

  • Spinal implant trial
Valeo TL Implant Trial, 11mm
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555910013311 ()
91.001.3311

  • Spinal implant trial
Valeo TL Implant Trial, 9mm
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555910013309 ()
91.001.3309

  • Spinal implant trial
Valeo TL Implant Trial, 7mm
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555910013307 ()
91.001.3307

  • Spinal implant trial
Nerve Root Retractor, 14mm
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555910012005 ()
91.001.2005

  • Internal spinal fixation procedure kit, reusable
Nerve Root Retractor, 6mm
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555910012004 ()
91.001.2004

  • Internal spinal fixation procedure kit, reusable
Osteotome Straight, 12
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555910011012 ()
91.001.1012

  • Internal spinal fixation procedure kit, reusable
Valeo TL, System Catalog Number Tag
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555910010024 ()
91.001.0024

  • Instrument tray, reusable
Valeo TL, System Name Tag
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555910010023 ()
91.001.0023

  • Instrument tray, reusable
Valeo II Universal Tray Lid
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555910009009 ()
91.000.9009

  • Instrument tray, reusable
Valeo II Prep Case Assembly
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555910009002 ()
91.000.9002

  • Instrument tray, reusable
Case / Tray Assembly
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555910009000 ()
91.000.9000

  • Instrument tray, reusable
1/4 Square Threaded Extender
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555910001303 ()
91.000.1303

  • Internal spinal fixation procedure kit, reusable
Slap Hammer Extension
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555910001220 ()
91.000.1220

  • Internal spinal fixation procedure kit, reusable
Valeo TL/PL Disc Prep, Aesculap Container and Lid Assembly
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555910000025 ()
91.000.0025

  • Instrument tray, reusable
Valeo TL/PL Disc Prep, System Catalog Number Tag
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555910000024 ()
91.000.0024

  • Instrument tray, reusable
Valeo TL/PL Disc Prep, System Name Tag
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555910000023 ()
91.000.0023

  • Instrument tray, reusable
Valeo C Tray Lid
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555910000013 ()
91.000.0013

  • Instrument tray, reusable
Taurus Pedicle Screw System- Headbody, Assembly, Reduction
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555510000002 ()
51-0000-002

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

  • M555509000002 ()
50-9000-002

  • 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
Final Tightening Driver
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555507000003 ()
50-7000-003

  • 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
Parallel Compressor, Wide
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555506000007 ()
50-6000-007

  • Internal spinal fixation procedure kit, reusable
Screw-to-screw Distractor
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555506000006 ()
50-6000-006

  • Orthopaedic surgical distractor, internal
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
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