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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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Valeo Spacer System - M555910073024

Valeo-PS, HeadLOC Inserter
AMEDICA CORPORATION
B
In Commercial Distribution

  • M555910073024 ()
91.007.3024

  • Bone-screw internal spinal fixation system, sterile

Valeo Spacer System - M555910073018

In-Situ Rod Bender Set for Ø5.5mm Rod
AMEDICA CORPORATION
B
In Commercial Distribution

  • M555910073018 ()
91.007.3018

  • Bone-screw internal spinal fixation system, sterile

Valeo Spacer System - M555910073017

In-Situ Rod Bender Set for Ø5.5mm Rod
AMEDICA CORPORATION
B
In Commercial Distribution

  • M555910073017 ()
91.007.3017

  • Bone-screw internal spinal fixation system, sterile

Valeo Spacer System - M555910073014

T-Handle Torque Limiting, 120 in-lbs 1/4" SQ Quick Connect
AMEDICA CORPORATION
B
In Commercial Distribution

  • M555910073014 ()
91.007.3014

  • Bone-screw internal spinal fixation system, sterile

Valeo Spacer System - M555910073002

Persuader
AMEDICA CORPORATION
B
In Commercial Distribution

  • M555910073002 ()
91.007.3002

  • Bone-screw internal spinal fixation system, sterile

Valeo Spacer System - M555910072002

Screw Depth Gauge
AMEDICA CORPORATION
B
In Commercial Distribution

  • M555910072002 ()
91.007.2002

  • Bone-screw internal spinal fixation system, sterile

Valeo Spacer System - M555910044016

PL Impactor
AMEDICA CORPORATION
B
In Commercial Distribution

  • M555910044016 ()
91.004.4016

  • Internal spinal fixation procedure kit, single-use

Valeo Spacer System - M555910044009

Initial Inserter Tip
AMEDICA CORPORATION
B
In Commercial Distribution

  • M555910044009 ()
91.004.4009

  • Internal spinal fixation procedure kit, single-use

Valeo Spacer System - M555910044004

Final Impactor
AMEDICA CORPORATION
B
In Commercial Distribution

  • M555910044004 ()
91.004.4004

  • Internal spinal fixation procedure kit, single-use

Valeo Spacer System - M555910044002

Packing Fixture
AMEDICA CORPORATION
B
In Commercial Distribution

  • M555910044002 ()
91.004.4002

  • Internal spinal fixation procedure kit, single-use

Valeo Spacer System - M555910043806

Rotating Cutter, 6mm
AMEDICA CORPORATION
B
In Commercial Distribution

  • M555910043806 ()
91.004.3806

  • Internal spinal fixation procedure kit, single-use

Valeo Spacer System - M555910043805

Rotating Cutter, 5mm
AMEDICA CORPORATION
B
In Commercial Distribution

  • M555910043805 ()
91.004.3805

  • Internal spinal fixation procedure kit, single-use

Valeo Spacer System - M555910043803

Rotating Cutter, 3mm
AMEDICA CORPORATION
B
In Commercial Distribution

  • M555910043803 ()
91.004.3803

  • Internal spinal fixation procedure kit, single-use

Valeo Spacer System - M555910040021

Valeo PL Case 1 Tray 2
AMEDICA CORPORATION
B
In Commercial Distribution

  • M555910040021 ()
91.004.0021

  • Internal spinal fixation procedure kit, single-use

Valeo Spacer System - M555910027012

C Trial 17x14, 12mm, 0° - 6° Stop
AMEDICA CORPORATION
B
In Commercial Distribution

  • M555910027012 ()

  • Height: 12 Millimeter
  • Width: 14 Millimeter
  • Length: 17 Millimeter
91.002.7012

  • Internal spinal fixation procedure kit, single-use

Valeo Spacer System - M555910027011

C Trial 17x14, 11mm, 0° - 6° Stop
AMEDICA CORPORATION
B
In Commercial Distribution

  • M555910027011 ()

  • Length: 17 Millimeter
  • Width: 14 Millimeter
  • Height: 11 Millimeter
91.002.7011

  • Internal spinal fixation procedure kit, single-use

Valeo Spacer System - M555910027010

C Trial 17x14, 10mm, 0° - 6° Stop
AMEDICA CORPORATION
B
In Commercial Distribution

  • M555910027010 ()

  • Height: 10 Millimeter
  • Width: 14 Millimeter
  • Length: 17 Millimeter
91.002.7010

  • Internal spinal fixation procedure kit, single-use

Valeo Spacer System - M555910027009

C Trial 17x14, 9mm, 0° - 6° Stop
AMEDICA CORPORATION
B
In Commercial Distribution

  • M555910027009 ()

  • Length: 17 Millimeter
  • Width: 14 Millimeter
  • Height: 9 Millimeter
91.002.7009

  • Internal spinal fixation procedure kit, single-use

Valeo Spacer System - M555910027008

C Trial 17x14, 8mm, 0° - 6° Stop
AMEDICA CORPORATION
B
In Commercial Distribution

  • M555910027008 ()

  • Height: 8 Millimeter
  • Width: 14 Millimeter
  • Length: 17 Millimeter
91.002.7008

  • Internal spinal fixation procedure kit, single-use

Valeo Spacer System - M555910027007

C Trial 17x14, 7mm, 0° - 6° Stop
AMEDICA CORPORATION
B
In Commercial Distribution

  • M555910027007 ()

  • Length: 17 Millimeter
  • Width: 14 Millimeter
  • Height: 7 Millimeter
91.002.7007

  • Internal spinal fixation procedure kit, single-use

Valeo Spacer System - M555910027006

C Trial 17x14, 6mm, 0° - 6° Stop
AMEDICA CORPORATION
B
In Commercial Distribution

  • M555910027006 ()

  • Height: 6 Millimeter
  • Width: 14 Millimeter
  • Length: 17 Millimeter
91.002.7006

  • Internal spinal fixation procedure kit, single-use

Valeo Spacer System - M555910027005

C Trial 17x14, 5mm, 0° - 6° Stop
AMEDICA CORPORATION
B
In Commercial Distribution

  • M555910027005 ()

  • Length: 17 Millimeter
  • Width: 14 Millimeter
  • Height: 5 Millimeter
91.002.7005

  • Internal spinal fixation procedure kit, single-use

Valeo Spacer System - M555910026012

C Trial 16x12, 12mm, 0° - 6° Stop
AMEDICA CORPORATION
B
In Commercial Distribution

  • M555910026012 ()

  • Height: 12 Millimeter
  • Width: 12 Millimeter
  • Length: 16 Millimeter
91.002.6012

  • Internal spinal fixation procedure kit, single-use

Valeo Spacer System - M555910026011

C Trial 16x12, 11mm, 0° - 6° Stop
AMEDICA CORPORATION
B
In Commercial Distribution

  • M555910026011 ()

  • Length: 16 Millimeter
  • Width: 12 Millimeter
  • Height: 11 Millimeter
91.002.6011

  • Internal spinal fixation procedure kit, single-use

Valeo Spacer System - M555910026010

C Trial 16x12, 10mm, 0° - 6° Stop
AMEDICA CORPORATION
B
In Commercial Distribution

  • M555910026010 ()

  • Height: 10 Millimeter
  • Width: 12 Millimeter
  • Length: 16 Millimeter
91.002.6010

  • Internal spinal fixation procedure kit, single-use

Valeo Spacer System - M555910026009

C Trial 16x12, 9mm, 0° - 6° Stop
AMEDICA CORPORATION
B
In Commercial Distribution

  • M555910026009 ()

  • Length: 16 Millimeter
  • Width: 12 Millimeter
  • Height: 9 Millimeter
91.002.6009

  • Internal spinal fixation procedure kit, single-use

Valeo Spacer System - M555910026008

C Trial 16x12, 8mm, 0° - 6° Stop
AMEDICA CORPORATION
B
In Commercial Distribution

  • M555910026008 ()

  • Height: 8 Millimeter
  • Width: 12 Millimeter
  • Length: 16 Millimeter
91.002.6008

  • Internal spinal fixation procedure kit, single-use

Valeo Spacer System - M555910026007

C Trial 16x12, 7mm, 0° - 6° Stop
AMEDICA CORPORATION
B
In Commercial Distribution

  • M555910026007 ()

  • Length: 16 Millimeter
  • Width: 12 Millimeter
  • Height: 7 Millimeter
91.002.6007

  • Internal spinal fixation procedure kit, single-use

Valeo Spacer System - M555910026005

C Trial 16x12, 5mm, 0° - 6° Stop
AMEDICA CORPORATION
B
In Commercial Distribution

  • M555910026005 ()

  • Height: 5 Millimeter
  • Width: 12 Millimeter
  • Length: 16 Millimeter
91.002.6005

  • Internal spinal fixation procedure kit, single-use

Valeo Spacer System - M555910025701

16x12 Insert Comp Ti Fork Stop Revision
AMEDICA CORPORATION
B
In Commercial Distribution

  • M555910025701 ()
91.002.5701

  • Internal spinal fixation procedure kit, single-use

Valeo Spacer System - M555910025011

Valeo C Starter, 16x12 with Depth Lines
AMEDICA CORPORATION
B
In Commercial Distribution

  • M555910025011 ()
91.002.5011

  • Internal spinal fixation procedure kit, single-use

Valeo Spacer System - M555910024001

Valeo-C Bone Packing Tamp
AMEDICA CORPORATION
B
Not in Commercial Distribution

  • M555910024001 ()
91.002.4001

  • Orthopaedic implant impactor, reusable

Valeo Spacer System - M555910021005

Casper Pin Driver
AMEDICA CORPORATION
B
Not in Commercial Distribution

  • M555910021005 ()
91.002.1005

  • Internal spinal fixation procedure kit, reusable

Valeo Spacer System - M555910021004

Casper Pin Distractor Right
AMEDICA CORPORATION
B
Not in Commercial Distribution

  • M555910021004 ()
91.002.1004

  • Internal spinal fixation procedure kit, reusable

Valeo Spacer System - M555910021003

Casper Pin Distractor Left
AMEDICA CORPORATION
B
Not in Commercial Distribution

  • M555910021003 ()
91.002.1003

  • Internal spinal fixation procedure kit, reusable

Valeo Spacer System - M555910020012

System Tag Case 3 - Valeo C
AMEDICA CORPORATION
B
Not in Commercial Distribution

  • M555910020012 ()
91.002.0012

  • Instrument tray, reusable

Valeo Spacer System - M555910020011

System Tag Case 3 - Valeo C
AMEDICA CORPORATION
B
Not in Commercial Distribution

  • M555910020011 ()
91.002.0011

  • Instrument tray, reusable

Valeo Spacer System - M555910020008

System Tag Case 2 - Valeo C
AMEDICA CORPORATION
B
Not in Commercial Distribution

  • M555910020008 ()
91.002.0008

  • Instrument tray, reusable

Valeo Spacer System - M555910020005

System Tag Case 1 - Valeo C
AMEDICA CORPORATION
B
Not in Commercial Distribution

  • M555910020005 ()
91.002.0005

  • Instrument tray, reusable

Valeo Spacer System - M555910014039

TL Extractor Tip, Cam, Ti, w/ Radel Bumper
AMEDICA CORPORATION
B
Not in Commercial Distribution

  • M555910014039 ()
91.001.4039

  • Surgical implant/trial-implant/sizer holder, reusable

Valeo Spacer System - M555910014038

TL Extractor Tip, Cam, Ti, w/ Ti Bumper
AMEDICA CORPORATION
B
Not in Commercial Distribution

  • M555910014038 ()
91.001.4038

  • Surgical implant/trial-implant/sizer holder, reusable

Valeo Spacer System - M555910014029

TL Cam Inserter Tip
AMEDICA CORPORATION
B
Not in Commercial Distribution

  • M555910014029 ()
91.001.4029

  • Surgical implant/trial-implant/sizer holder, reusable

Valeo Spacer System - M555910014016

TL Final Impactor
AMEDICA CORPORATION
B
Not in Commercial Distribution

  • M555910014016 ()
91.001.4016

  • Orthopaedic implant impactor, reusable

Valeo Spacer System - M555910014015

Impactor Angled Large
AMEDICA CORPORATION
B
Not in Commercial Distribution

  • M555910014015 ()
91.001.4015

  • Orthopaedic implant impactor, reusable

Valeo Spacer System - M555910014005

Impactor Angled Small
AMEDICA CORPORATION
B
Not in Commercial Distribution

  • M555910014005 ()
91.001.4005

  • Orthopaedic implant impactor, reusable

Valeo Spacer System - M555910014002

Packing Fixture
AMEDICA CORPORATION
B
Not in Commercial Distribution

  • M555910014002 ()
91.001.4002

  • Orthopaedic implant impactor, reusable

Valeo Spacer System - M555910013417

Mini Trial, 17mm
AMEDICA CORPORATION
B
Not in Commercial Distribution

  • M555910013417 ()
91.001.3417

  • Spinal implant trial

Valeo Spacer System - M555910013415

Mini Trial, 15mm
AMEDICA CORPORATION
B
Not in Commercial Distribution

  • M555910013415 ()
91.001.3415

  • Spinal implant trial

Valeo Spacer System - M555910013413

Mini Trial, 13mm
AMEDICA CORPORATION
B
Not in Commercial Distribution

  • M555910013413 ()
91.001.3413

  • Spinal implant trial

Valeo Spacer System - M555910013411

Mini Trial, 11mm
AMEDICA CORPORATION
B
Not in Commercial Distribution

  • M555910013411 ()
91.001.3411

  • Spinal implant trial
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