SpeedAkin

GUDID 00810111223744

Rapid Compression Implants

Treace Medical Concepts, Inc.

Orthopaedic bone staple, non-adjustable
Primary Device ID00810111223744
NIH Device Record Keya5fa5490-5bf4-4bc8-8b45-fdb9352d2448
Commercial Distribution StatusIn Commercial Distribution
Brand NameSpeedAkin
Version Model NumberSK63
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 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
GS100810111223744 [Primary]

FDA Product Code

JDRStaple, Fixation, Bone

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-02-04
Device Publish Date2025-01-27

Devices Manufactured by Treace Medical Concepts, Inc.

00810111224499 - Drill Guide2025-09-22 Drill Guide and Template
00810111223904 - Targeting Guide2025-09-04 Trajectory Guide
00810111223911 - Targeting Guide2025-09-04 Guide Targeter
00810111223928 - Targeting Guide2025-09-04 Guide Body
00810111223935 - Cut Guide2025-09-04 Cut Guide
00810111225076 - Drill Tack2025-09-04 2.9MM Tack
00810111223874 - K-wire Sleeve2025-09-03 4mm Short Sleeve
00810111223881 - K-wire Sleeve2025-09-03 3mm Long Sleeve

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