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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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Sounder, Straight
AMEDICA CORPORATION
G
Not in Commercial Distribution

  • M555112200002 ()
11-2200-002

  • Internal spinal fixation procedure kit, reusable
Sounder, Curved
AMEDICA CORPORATION
G
Not in Commercial Distribution

  • M555112200001 ()
11-2200-001

  • Internal spinal fixation procedure kit, reusable
1/4" Quick Connect Palm Handle
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555112100010 ()
11-2100-010

  • Internal spinal fixation procedure kit, reusable
Probe, Straight-Half Moon Tip Shaft, 1/4" Quick Connect
AMEDICA CORPORATION
A
Not in Commercial Distribution

  • M555112100009 ()
11-2100-009

  • Internal spinal fixation procedure kit, reusable
Pedicle Probe, Straight
AMEDICA CORPORATION
F
Not in Commercial Distribution

  • M555112100004 ()
11-2100-004

  • Internal spinal fixation procedure kit, reusable
Pedicle Probe, Curved
AMEDICA CORPORATION
F
Not in Commercial Distribution

  • M555112100003 ()
11-2100-003

  • Internal spinal fixation procedure kit, reusable
Pedicle Probe, Straight
AMEDICA CORPORATION
F
Not in Commercial Distribution

  • M555112100002 ()
11-2100-002

  • Internal spinal fixation procedure kit, reusable
Pedicle Probe, Curved
AMEDICA CORPORATION
F
Not in Commercial Distribution

  • M555112100001 ()
11-2100-001

  • Internal spinal fixation procedure kit, reusable
ø4.5 x 25mm Polyaxial Screw Assembly
AMEDICA CORPORATION
C
Not in Commercial Distribution

  • M555284500025 ()

  • Outer Diameter: 4.5 Millimeter
  • Length: 25 Millimeter
28-4500-025

  • Spinal bone screw, non-bioabsorbable
Long Rod Template, 5.5mm x 400mm
AMEDICA CORPORATION
B
Not in Commercial Distribution

  • M555284000400 ()
28-4000-400

  • Spinal implant trial
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