Identity
- Trade Name
- Torx Threaded Peg FDA UDI
- Generic Name
- Orthopaedic bone screw (non-sliding) FDA UDI
- Device Name
- Torx Threaded Peg, 22mm FDA UDI
- Model / Reference
- TPEG-22 FDA UDI
- Description
- Torx Threaded Peg, 22mm FDA UDI
Identifiers
- Catalog Number
- TPEG-22 FDA UDI
- Primary DI / UDI-DI
- 00842188108396 FDA UDI
- 510(k) Number
- K040112 FDA UDI
- FDA Product Code
- JDS FDA UDI
- GMDN Term
- Orthopaedic bone screw (non-sliding) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3030 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Orthopaedic bone screw (non-sliding)
Torx Threaded Peg by Trimed, INC. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Orthopaedic bone screw (non-sliding).
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Cleared under the same submission
K040112 also covers:
- Radial Shortening Plate — Trimed, INC.
- Radial Shortening Plate — Trimed, INC.
- S.A. - Volar Bearing Plates — Trimed, INC.
- S.A. - Volar Bearing Plates — Trimed, INC.
- S.A. - Volar Bearing Plates — Trimed, INC.
- S.A. - Volar Bearing Plates — Trimed, INC.
- S.A. - Volar Bearing Plates — Trimed, INC.
- S.A. - Volar Bearing Plates — Trimed, INC.
- S.A. - Volar Bearing Plates — Trimed, INC.
- S.A. - Volar Bearing Plates — Trimed, INC.
- S.A. - Volar Bearing Plates — Trimed, INC.
- S.A. - Volar Bearing Plates — Trimed, INC.
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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Trimed, INC.
Sources (1)
- FDA UDI 22176f05-a3d8-489f-9176-7c665b2528f1 36 fields · synced May 31, 2026