TMC SpeedTMT

GUDID 00810111225373

Inserter Rod

Treace Medical Concepts, Inc.

Orthopaedic bone screw (non-sliding)
Primary Device ID00810111225373
NIH Device Record Keybe5c63a8-d1a3-428f-9392-a247cfdca0e1
Commercial Distribution StatusIn Commercial Distribution
Brand NameTMC SpeedTMT
Version Model Number02-00414
Company DUNS054808082
Company NameTreace Medical Concepts, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100810111225373 [Primary]

FDA Product Code

JDRStaple, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00810111225373]

Moist Heat or Steam Sterilization


[00810111225373]

Moist Heat or Steam Sterilization


[00810111225373]

Moist Heat or Steam Sterilization


[00810111225373]

Moist Heat or Steam Sterilization


[00810111225373]

Moist Heat or Steam Sterilization


[00810111225373]

Moist Heat or Steam Sterilization


[00810111225373]

Moist Heat or Steam Sterilization


[00810111225373]

Moist Heat or Steam Sterilization


[00810111225373]

Moist Heat or Steam Sterilization


[00810111225373]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-12-22
Device Publish Date2025-12-12

On-Brand Devices [TMC SpeedTMT]

00810111225373Inserter Rod
00810111225199Rapid Compression Implants
00810111225175Inserter Cap

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