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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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Streamline TL Spinal Fixation System - 00846468001629

RATCHETING PALM HANDLE, 1/4" SDQC
Xtant Medical Holdings, Inc.
10-RPHANDLE
Not in Commercial Distribution

10-RPHANDLE

  • Surgical instrument handle, non-torque-limiting

Streamline TL Spinal Fixation System - 00846468001612

ROD TEMPLATE
Xtant Medical Holdings, Inc.
10-RODTEMPLATE
Not in Commercial Distribution

10-RODTEMPLATE

  • Surgical implant template, reusable

Streamline TL Spinal Fixation System - 00846468001605

ROD FORCEPS, STRAIGHT, Ø 5.5mm
Xtant Medical Holdings, Inc.
10-RODFORCEP-S
Not in Commercial Distribution

10-RODFORCEP-S

  • Orthopaedic inorganic implant inserter/extractor, reusable

Streamline TL Spinal Fixation System - 00846468001599

ROD CUTTER
Xtant Medical Holdings, Inc.
10-RODCUTTER
Not in Commercial Distribution

10-RODCUTTER

  • Orthopaedic implantable-device cutter

Streamline TL Spinal Fixation System - 00846468001582

DRIVER, ROD TO ROD
Xtant Medical Holdings, Inc.
10-RDDRIVER
Not in Commercial Distribution

10-RDDRIVER

  • Surgical screwdriver, reusable

Streamline TL Spinal Fixation System - 00846468001575

DISTRACTOR, RADIAL, Ø 5.5mm
Xtant Medical Holdings, Inc.
10-RADIALDIST
Not in Commercial Distribution

10-RADIALDIST

  • Orthopaedic fixation implant alignment tool

Streamline TL Spinal Fixation System - 00846468001568

COMPRESSOR, RADIAL, Ø 5.5mm
Xtant Medical Holdings, Inc.
10-RADIALCOMP
Not in Commercial Distribution

10-RADIALCOMP

  • Orthopaedic fixation implant alignment tool

Streamline TL Spinal Fixation System - 00846468001551

ROD PUSHER
Xtant Medical Holdings, Inc.
10-PUSHER
Not in Commercial Distribution

10-PUSHER

  • Surgical implant/trial-implant/sizer holder, reusable

Streamline TL Spinal Fixation System - 00846468001544

PALM STYLE HANDLE
Xtant Medical Holdings, Inc.
10-PHANDLE
Not in Commercial Distribution

10-PHANDLE

  • Surgical instrument handle, non-torque-limiting

Streamline TL Spinal Fixation System - 00846468001537

PEDICLE MARKER, 90mm
Xtant Medical Holdings, Inc.
10-MARKER-90
Not in Commercial Distribution

10-MARKER-90

  • Orthopaedic prosthesis implantation positioning instrument, reusable
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