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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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Preference II Screw to Screw Distractor
AMEDICA CORPORATION
B
Not in Commercial Distribution

  • M555275000003 ()
27-5000-003

  • Internal spinal fixation procedure kit, reusable
Tab Breaker
AMEDICA CORPORATION
B
Not in Commercial Distribution

  • M555274000008 ()
27-4000-008

  • Internal spinal fixation procedure kit, reusable
Awl - Silicon Handle
AMEDICA CORPORATION
B
Not in Commercial Distribution

  • M555274000007 ()
27-4000-007

  • Internal spinal fixation procedure kit, reusable
Head Positioner - Rod Pusher
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555274000006 ()
27-4000-006

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

  • M555274000005 ()
27-4000-005

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

  • M555274000004 ()
27-4000-004

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

  • M555273000001 ()
27-3000-001

  • Internal spinal fixation procedure kit, reusable
Final Tightening Driver
AMEDICA CORPORATION
B
Not in Commercial Distribution

  • M555272000010 ()
27-2000-010

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

  • M555272000003 ()
27-2000-003

  • Internal spinal fixation procedure kit, reusable
Polyaxial Screw Driver Assembly
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555272000001 ()
27-2000-001

  • Internal spinal fixation procedure kit, reusable
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