Primary Device ID | 00810111223744 |
NIH Device Record Key | a5fa5490-5bf4-4bc8-8b45-fdb9352d2448 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | SpeedAkin |
Version Model Number | SK63 |
Company DUNS | 054808082 |
Company Name | Treace Medical Concepts, Inc. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00810111223744 [Primary] |
JDR | Staple, Fixation, Bone |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2025-02-04 |
Device Publish Date | 2025-01-27 |
00810111224499 - Drill Guide | 2025-09-22 Drill Guide and Template |
00810111223904 - Targeting Guide | 2025-09-04 Trajectory Guide |
00810111223911 - Targeting Guide | 2025-09-04 Guide Targeter |
00810111223928 - Targeting Guide | 2025-09-04 Guide Body |
00810111223935 - Cut Guide | 2025-09-04 Cut Guide |
00810111225076 - Drill Tack | 2025-09-04 2.9MM Tack |
00810111223874 - K-wire Sleeve | 2025-09-03 4mm Short Sleeve |
00810111223881 - K-wire Sleeve | 2025-09-03 3mm Long Sleeve |