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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 - M555911111003

Valeo II TL Fixed Inserter
AMEDICA CORPORATION
E
In Commercial Distribution

  • M555911111003 ()
91.111.1003

  • Internal spinal fixation procedure kit, single-use

Preference 2 - M555211000020

Stabilizing Sleeve
AMEDICA CORPORATION
E
Not in Commercial Distribution

  • M555211000020 ()
21-1000-020

  • Internal spinal fixation procedure kit, reusable

Preference 2 - M555159000329

8.2mm Caddy Block
AMEDICA CORPORATION
E
Not in Commercial Distribution

  • M555159000329 ()
15-9000-329

  • Device sterilization/disinfection container, reusable

Preference 2 - M555116000001

Preference II Pedicle Screw System, Implant Case
AMEDICA CORPORATION
E
Not in Commercial Distribution

  • M555116000001 ()
11-6000-001

  • Device sterilization/disinfection container, reusable

Preference 2 - M555115000002

Distractor, Single Lever
AMEDICA CORPORATION
E
Not in Commercial Distribution

  • M555115000002 ()
11-5000-002

  • Orthopaedic surgical distractor, internal

Preference 2 - M555115000001

Compressor, Single Level
AMEDICA CORPORATION
E
Not in Commercial Distribution

  • M555115000001 ()
11-5000-001

  • Internal spinal fixation procedure kit, reusable

Preference 2 - M555114000034

Blocker Tightener, Provisional
AMEDICA CORPORATION
E
Not in Commercial Distribution

  • M555114000034 ()
11-4000-034

  • Internal spinal fixation procedure kit, reusable

Preference 2 - M555114000005

Power Rod Holder, 6mm Diameter
AMEDICA CORPORATION
E
Not in Commercial Distribution

  • M555114000005 ()
11-4000-005

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

Preference 2 - M555114000004

Rod Holder
AMEDICA CORPORATION
E
Not in Commercial Distribution

  • M555114000004 ()
11-4000-004

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

Taurus Pedicle Screw System - M555114000001

Rod Bender, French
AMEDICA CORPORATION
E
Not in Commercial Distribution

  • M555114000001 ()
11-4000-001

  • Manual orthopaedic bender, reusable
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