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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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CONTACT ALP Anterior Lumbar Plate System - 00846468003692

PLATE HOLDER
Pioneer Surgical Technology, Inc.
25-HOLDER
Not in Commercial Distribution

25-HOLDER

  • General internal orthopaedic fixation system implantation kit

Quantum Spinal Fixation System - 00846468001988

ELEVATOR, PEDICLE
Pioneer Surgical Technology, Inc.
10-ELEVATOR-P
Not in Commercial Distribution

10-ELEVATOR-P

  • General internal orthopaedic fixation system implantation kit

Streamline TL Spinal Fixation System - 00846468001759

ROD TEMPLATE
Xtant Medical Holdings, Inc.
10-TEMPLATE-250
Not in Commercial Distribution

10-TEMPLATE-250

  • Surgical implant template, reusable

Streamline TL Spinal Fixation System - 00846468001735

FIXED STRAIGHT HANDLE, 1/4" SDQC
Xtant Medical Holdings, Inc.
10-SHANDLE
Not in Commercial Distribution

10-SHANDLE

  • Surgical instrument handle, non-torque-limiting

Streamline TL Spinal Fixation System - 00846468001711

PEDICLE FINDER, STRAIGHT, LENKE, LONG
Xtant Medical Holdings, Inc.
10-SFINDER-LE-L
Not in Commercial Distribution

10-SFINDER-LE-L

  • Abdominal/ENT/orthopaedic surgical probe, reusable

Streamline TL Spinal Fixation System - 00846468001698

PEDICLE FINDER, STRAIGHT
Xtant Medical Holdings, Inc.
10-SFINDER
Not in Commercial Distribution

10-SFINDER

  • Abdominal/ENT/orthopaedic surgical probe, reusable

Streamline TL Spinal Fixation System - 00846468001650

BALLTIP, STRAIGHT
Xtant Medical Holdings, Inc.
10-SBALLTIP
Not in Commercial Distribution

10-SBALLTIP

  • Abdominal/ENT/orthopaedic surgical probe, reusable

Streamline TL Spinal Fixation System - 00846468001636

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

10-RSHANDLE

  • Surgical instrument handle, non-torque-limiting

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
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