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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 - 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
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