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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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Apache - M719GP638L050

Large Cervical Trial with Handle, No Stop
Genesys Orthopedics Systems LLC
1
In Commercial Distribution

  • M719GP638L050 ()

  • Length: 5 Millimeter
GP638-L05

  • Vertebral body prosthesis, non-sterile

VSP - 10705034008929

VSP SPINE SYSTEM WASHER WITH GROOVE 5.0mm
DEPUY SPINE, LLC
22261215
Not in Commercial Distribution

  • 10705034008929 ()
22261215

  • Bone-screw internal spinal fixation system, non-sterile

ISOLA - 10705034001074

ISOLA SPINE SYSTEM ASSEMBLY WITH CENTER NUT
DEPUY SPINE, LLC
203080
Not in Commercial Distribution

  • 10705034001074 ()
203080

  • Bone-screw internal spinal fixation system, non-sterile

PHOENIX - 18257200116058

Pre-Lordosed Rod with Hex and Taper, 200mm
Orthofix US LLC
20-4200
In Commercial Distribution

  • 18257200116058 ()

  • Length: 150 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile

PHOENIX - 18257200080229

Pre-Lordosed Rod with Hex and Taper, 200mm
Orthofix US LLC
20-4200
In Commercial Distribution

  • 18257200080229 ()

  • Length: 150 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile

TiLock - M719GL201TIB0

T-Ratchet Handle with Impact Cap (Black Handle)
Genesys Orthopedics Systems LLC
1
In Commercial Distribution

  • M719GL201TIB0 ()
GL201TI-B

  • Bone-screw internal spinal fixation system, non-sterile

Nautilus Spinal System - 00190837057909

Custom Rod Bender, with orange silicone inserts
Life Spine, Inc.
RB101009-AH
In Commercial Distribution

  • 00190837057909 ()
RB101009-AH

  • Bone-screw internal spinal fixation system, non-sterile

Nautilus Spinal System - 00190837056513

Custom Lenke Probe with Luer Lock Connection
Life Spine, Inc.
2017-0119
In Commercial Distribution

  • 00190837056513 ()
2017-0119

  • Bone-screw internal spinal fixation system, non-sterile

FS3 Facet Screw Spinal System - 00190837041489

Facet Screw Driver, Mid Length with Flats
Life Spine, Inc.
2017-0090
In Commercial Distribution

  • 00190837041489 ()
2017-0090

  • Bone-screw internal spinal fixation system, non-sterile

BacFix® - 00887868260193

Unit Rod with 1/4” Ilium Extensions
ZIMMER BIOMET INC
819-39
In Commercial Distribution

  • 00887868260193 ()


  • Bone-screw internal spinal fixation system, non-sterile
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