SpeedMTP Compression Screws

GUDID 00810111223515

Headless Compression Screws

Treace Medical Concepts, Inc.

Orthopaedic bone screw (non-sliding)
Primary Device ID00810111223515
NIH Device Record Keye4876a8d-351f-46fb-904f-2c588a75954a
Commercial Distribution StatusIn Commercial Distribution
Brand NameSpeedMTP Compression Screws
Version Model NumberSK60
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 Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100810111223515 [Primary]

FDA Product Code

HWCScrew, Fixation, Bone

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-11-14
Device Publish Date2024-11-06

Devices Manufactured by Treace Medical Concepts, Inc.

00810111224512 - Saw Blade2025-05-16 FeatherRasp - ZMS
00810111224482 - Scalpel 2025-05-14 MTP Release Instrument
00810111224505 - Saw Blade2025-05-14 FeatherRasp - SM
00810111224321 - Reamer2025-05-02 18mm cup reamer
00810111224338 - Reamer2025-05-02 18mm cone reamer
00810111224345 - Reamer2025-05-02 21mm cup reamer
00810111224352 - Reamer2025-05-02 21mm cone reamer
00810111224369 - Reamer2025-05-02 23mm cup reamer

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