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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 - 00846468001643

T-HANDLE, RATCHETING
Xtant Medical Holdings, Inc.
10-RTHANDLE
Not in Commercial Distribution

10-RTHANDLE

  • 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 - 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 - 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 - 00846468001513

ROD GRIPPER, SMALL
Xtant Medical Holdings, Inc.
10-GRIPPER-S
Not in Commercial Distribution

10-GRIPPER-S

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

Streamline TL Spinal Fixation System - 00846468001452

ROD CUTTER CARTRIDGE
Xtant Medical Holdings, Inc.
10-CUTCART-55
Not in Commercial Distribution

10-CUTCART-55

  • Orthopaedic implantable-device cutter

Streamline TL Spinal Fixation System - 00846468001445

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

10-COMPRESSOR

  • Orthopaedic fixation implant alignment tool

Streamline TL Spinal Fixation System - 00846468001438

PEDICLE FINDER, CURVED, SMALL, SQUARE TIP
Xtant Medical Holdings, Inc.
10-CFINDER-SM-S
Not in Commercial Distribution

10-CFINDER-SM-S

  • Abdominal/ENT/orthopaedic surgical probe, reusable

Streamline TL Spinal Fixation System - 00846468001414

BALLTIP, CURVED
Xtant Medical Holdings, Inc.
10-CBALLTIP
Not in Commercial Distribution

10-CBALLTIP

  • Abdominal/ENT/orthopaedic surgical probe, reusable

Streamline TL Spinal Fixation System - 00846468001407

PEDICLE MARKER, BANDED
Xtant Medical Holdings, Inc.
10-BMARKER
Not in Commercial Distribution

10-BMARKER

  • Orthopaedic prosthesis implantation positioning instrument, reusable
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