Identity
- Trade Name
- TMC PSI Cut Guide System FDA UDI
- Generic Name
- Drilling power tool attachment, basic FDA UDI
- Device Name
- Fixation Kit FDA UDI
- Model / Reference
- NK28 FDA UDI
- Description
- Fixation Kit FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810111223614 FDA UDI
- FDA Product Code
- HWE FDA UDI
- GMDN Term
- Drilling power tool attachment, basic FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4820 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Drilling power tool attachment, basicOrthopaedic intraoperative positioning pin, single-use
TMC PSI Cut Guide System by Treace Medical Concepts, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic intraoperative positioning pin, single-use.
- Peri-Loc — Smith & Nephew, Inc. · Class II
- Prodigy Pedicle Screw System — Curiteva, LLC · Class II
- Guide Screw Headless Threaded — Gebr. Brasseler GmbH & Co. KG · Class II
- K-Wire, 0.9mm x 120mm Long — AVANTI ORTHOPAEDICS LLC · Class II
- Guide Screw — Gebr. Brasseler GmbH & Co. KG · Class II
- Stratum — Medartis Inc. · Class I
- AETOS Shoulder System — Smith & Nephew, Inc. · Class I
- KOMET GUIDE PIN/SCREW — Gebr. Brasseler GmbH & Co. KG · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Treace Medical Concepts, Inc.
Sources (1)
- FDA UDI 6dd2bb82-937c-410a-81b0-d1ad02c7862e 33 fields · synced Jun 6, 2026