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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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ø5.5 Triple Lead Closed Polyaxial Screw Assembly, 40mm
AMEDICA CORPORATION
B
Not in Commercial Distribution

  • M555285552040 ()

  • Length: 40 Millimeter
  • Outer Diameter: 5.5 Millimeter
28-5552-040

  • Spinal bone screw, non-bioabsorbable
ø5.5 Triple Lead Closed Polyaxial Screw Assembly, 35mm
AMEDICA CORPORATION
B
Not in Commercial Distribution

  • M555285552035 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 35 Millimeter
28-5552-035

  • Spinal bone screw, non-bioabsorbable
ø5.5 Triple Lead Closed Polyaxial Screw Assembly, 30mm
AMEDICA CORPORATION
B
Not in Commercial Distribution

  • M555285552030 ()

  • Length: 30 Millimeter
  • Outer Diameter: 5.5 Millimeter
28-5552-030

  • Spinal bone screw, non-bioabsorbable
ø5.5 Triple Lead Closed Polyaxial Screw Assembly, 25mm
AMEDICA CORPORATION
B
Not in Commercial Distribution

  • M555285552025 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 25 Millimeter
28-5552-025

  • 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
7.2mm Polyaxial Screw Caddy, Complex Spine Tray 4
AMEDICA CORPORATION
B
Not in Commercial Distribution

  • M555281000053 ()
28-1000-053

  • Device sterilization/disinfection container, reusable
6.5mm Polyaxial Screw Caddy, Complex Spine Tray 4
AMEDICA CORPORATION
B
Not in Commercial Distribution

  • M555281000052 ()
28-1000-052

  • Device sterilization/disinfection container, reusable
5.5mm Polyaxial Screw Caddy, Complex Spine Tray 4
AMEDICA CORPORATION
B
Not in Commercial Distribution

  • M555281000051 ()
28-1000-051

  • Device sterilization/disinfection container, reusable
4.5mm Polyaxial Screw Caddy, Complex Spine Tray 4
AMEDICA CORPORATION
B
Not in Commercial Distribution

  • M555281000050 ()
28-1000-050

  • Device sterilization/disinfection container, reusable
Preference 2 Plus Tray 2
AMEDICA CORPORATION
B
Not in Commercial Distribution

  • M555277000014 ()
27-7000-014

  • Instrument tray, reusable
Preference 2 Plus Base 2
AMEDICA CORPORATION
B
Not in Commercial Distribution

  • M555277000013 ()
27-7000-013

  • Instrument tray, reusable
Preference 2 Plus Tray 1
AMEDICA CORPORATION
B
Not in Commercial Distribution

  • M555277000012 ()
27-7000-012

  • Instrument tray, reusable
Preference 2 Plus Base 1
AMEDICA CORPORATION
B
Not in Commercial Distribution

  • M555277000011 ()
27-7000-011

  • Instrument tray, reusable
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
Counter Torque
AMEDICA CORPORATION
B
Not in Commercial Distribution

  • M555274000005 ()
27-4000-005

  • 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
Rod Connector, Short, 5.5-6.0 Rod Assembly
AMEDICA CORPORATION
B
Not in Commercial Distribution

  • M555252400003 ()

  • Outer Diameter: 5.5 Millimeter
25-2400-003

  • Bone-screw internal spinal fixation system connector
Side-to-Side Connector Assembly, 5.5mm
AMEDICA CORPORATION
B
Not in Commercial Distribution

  • M555252300055 ()

  • Outer Diameter: 5.5 Millimeter
25-2300-055

  • Bone-screw internal spinal fixation system connector
PLIF Inserter 10mm
AMEDICA CORPORATION
B
Not in Commercial Distribution

  • M555317200001 ()
31-7200-001

  • Surgical implant/trial-implant/sizer holder, reusable
30-Dg_R_Serrated_#1
AMEDICA CORPORATION
B
Not in Commercial Distribution

  • M555315200008 ()
31-5200-008

  • Internal spinal fixation procedure kit, reusable
30-Dg_Lf_Serrated_#1
AMEDICA CORPORATION
B
Not in Commercial Distribution

  • M555315200006 ()
31-5200-006

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

  • M555315200001 ()
31-5200-001

  • Internal spinal fixation procedure kit, reusable
Cobb Elevator
AMEDICA CORPORATION
B
Not in Commercial Distribution

  • M555315100025 ()
31-5100-025

  • Internal spinal fixation procedure kit, reusable
Cobb Elevator
AMEDICA CORPORATION
B
Not in Commercial Distribution

  • M555315100019 ()
31-5100-019

  • Internal spinal fixation procedure kit, reusable
Complex Spine System Hook, Laminar Small, Narrow Blade 5.5
AMEDICA CORPORATION
B
Not in Commercial Distribution

  • M555289000160 ()
28-9000-160

  • Bone-screw internal spinal fixation system hook
Hook Holder Curved Forceps
AMEDICA CORPORATION
B
Not in Commercial Distribution

  • M555246000024 ()
24-6000-024

  • Internal spinal fixation procedure kit, reusable
Straight Forceps Hook Holder
AMEDICA CORPORATION
B
Not in Commercial Distribution

  • M555246000021 ()
24-6000-021

  • Internal spinal fixation procedure kit, reusable
Hook Inserter, Pusher
AMEDICA CORPORATION
B
Not in Commercial Distribution

  • M555246000012 ()
24-6000-012

  • Internal spinal fixation procedure kit, reusable
Preference 2 Mini Set Screw Caddy Assembly
AMEDICA CORPORATION
B
Not in Commercial Distribution

  • M555244000163 ()
24-4000-163

  • Instrument tray, reusable
Forceps Persuader, Assy.
AMEDICA CORPORATION
B
Not in Commercial Distribution

  • M555244000125 ()
24-4000-125

  • Internal spinal fixation procedure kit, reusable
Persuader Shaft
AMEDICA CORPORATION
B
Not in Commercial Distribution

  • M555244000103 ()
24-4000-103

  • Internal spinal fixation procedure kit, reusable
5.5mm Rod Holder Assembly - Holmed
AMEDICA CORPORATION
B
Not in Commercial Distribution

  • M555244000091 ()
24-4000-091

  • Internal spinal fixation procedure kit, reusable
Ratcheting T-handle Torque Wrench, 80 in-lb
AMEDICA CORPORATION
B
Not in Commercial Distribution

  • M555244000067 ()
24-4000-067

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

  • M555244000036 ()
24-4000-036

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

  • M555244000035 ()
24-4000-035

  • Internal spinal fixation procedure kit, reusable
Awl (Radel Handle)
AMEDICA CORPORATION
B
Not in Commercial Distribution

  • M555244000034 ()
24-4000-034

  • Internal spinal fixation procedure kit, reusable
Manipulation Sticks (Derotaion) Complex Spine
AMEDICA CORPORATION
B
Not in Commercial Distribution

  • M555244000021 ()
24-4000-021

  • Internal spinal fixation procedure kit, reusable
Coronal Bender, Left
AMEDICA CORPORATION
B
Not in Commercial Distribution

  • M555244000009 ()
24-4000-009

  • Manual orthopaedic bender, reusable
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