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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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Case 3, Tray 2 - Valeo C
AMEDICA CORPORATION
D
In Commercial Distribution

  • M555910020010 ()
91.002.0010

  • Internal spinal fixation procedure kit, single-use
Case 3, Tray 1 - Valeo C
AMEDICA CORPORATION
D
In Commercial Distribution

  • M555910020009 ()
91.002.0009

  • Internal spinal fixation procedure kit, single-use
System Tag Case 2 - Valeo C
AMEDICA CORPORATION
B
In Commercial Distribution

  • M555910020008 ()
91.002.0008

  • Internal spinal fixation procedure kit, single-use
Case 2, Tray 2 - Valeo C
AMEDICA CORPORATION
D
In Commercial Distribution

  • M555910020007 ()
91.002.0007

  • Internal spinal fixation procedure kit, single-use
Case 2, Tray 1 - Valeo C
AMEDICA CORPORATION
D
In Commercial Distribution

  • M555910020006 ()
91.002.0006

  • Internal spinal fixation procedure kit, single-use
System Tag Case 1 - Valeo C
AMEDICA CORPORATION
B
In Commercial Distribution

  • M555910020005 ()
91.002.0005

  • Internal spinal fixation procedure kit, single-use
Case 1, Tray 1 - Valeo C
AMEDICA CORPORATION
D
In Commercial Distribution

  • M555910020003 ()
91.002.0003

  • Internal spinal fixation procedure kit, single-use
Mallet 500g Metal Cap, 30mm
AMEDICA CORPORATION
A
In Commercial Distribution

  • M555910015116 ()
91.001.5116

  • Bone-screw internal spinal fixation system, sterile
TL Extractor Tip, Cam, Ti, w/ Radel Bumper
AMEDICA CORPORATION
B
In Commercial Distribution

  • M555910014039 ()
91.001.4039

  • Bone-screw internal spinal fixation system, sterile
Valeo TL Trial Full Size, 7mm
AMEDICA CORPORATION
A
In Commercial Distribution

  • M555910013507 ()
91.001.3507

  • Bone-screw internal spinal fixation system, sterile
Mini Trial, 15mm
AMEDICA CORPORATION
B
In Commercial Distribution

  • M555910013415 ()
91.001.3415

  • Bone-screw internal spinal fixation system, sterile
Valeo TL Implant Trial, 9mm
AMEDICA CORPORATION
A
In Commercial Distribution

  • M555910013309 ()
91.001.3309

  • Bone-screw internal spinal fixation system, sterile
Paddle Distractor 17
AMEDICA CORPORATION
K
In Commercial Distribution

  • M555910013217 ()
91.001.3117

  • Internal spinal fixation procedure kit, single-use
Rotating Cutter, 8mm
AMEDICA CORPORATION
D
In Commercial Distribution

  • M555910013108 ()
91.001.3108

  • Bone-screw internal spinal fixation system, sterile
Rasp Angled
AMEDICA CORPORATION
C
In Commercial Distribution

  • M555910013011 ()
91.001.3011

  • Internal spinal fixation procedure kit, single-use
Valeo Straight Rasp
AMEDICA CORPORATION
E
In Commercial Distribution

  • M555910013010 ()
91.001.3010

  • Internal spinal fixation procedure kit, single-use
Gauthier 1/4 - Square QC Impaction Handle
AMEDICA CORPORATION
C
In Commercial Distribution

  • M555910013009 ()
91.001.3009

  • Internal spinal fixation procedure kit, single-use
Angled Ring Long
AMEDICA CORPORATION
C
In Commercial Distribution

  • M555910013008 ()
91.001.3008

  • Internal spinal fixation procedure kit, single-use
PLIF P-tanium 26mm x 10mm x 7mm x 8 °
Tyber Medical LLC
PPT-P267810-S
In Commercial Distribution

  • M695PPTP267810S0 ()
PPT-P267810-S

  • Metal-polymer composite spinal interbody fusion cage
PLIF P-tanium 26mm x 10mm x 7mm x 0 deg
Tyber Medical LLC
PPT-P267010-S
In Commercial Distribution

  • M695PPTP267010S0 ()
PPT-P267010-S

  • Metal-polymer composite spinal interbody fusion cage
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