Identity
- Trade Name
- 2.7 Cortical Screw FDA UDI
- Generic Name
- Orthopaedic bone screw (non-sliding) FDA UDI
- Device Name
- Cortical Screw 2.7, 50mm, T8, Ti FDA UDI
- Model / Reference
- TRXC2.7-50 T FDA UDI
- Description
- Cortical Screw 2.7, 50mm, T8, Ti FDA UDI
Identifiers
- Catalog Number
- TRXC2.7-50 T FDA UDI
- Primary DI / UDI-DI
- 00842188117435 FDA UDI
- 510(k) Number
- K050681 FDA UDI
- FDA Product Code
- HWC FDA UDI
- GMDN Term
- Orthopaedic bone screw (non-sliding) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3040 FDA UDI
- Commercial Distribution
- Not 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
2.7 Cortical Screw by Trimed, INC. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K050681 also covers:
- 2.3 Cortical Screw — Trimed, INC.
- 2.3 Cortical Screw — Trimed, INC.
- 2.3 VA Locking Screw — Trimed, INC.
- 2.3 VA Locking Screw — Trimed, INC.
- 2.3 VA Locking Screw — Trimed, INC.
- 2.7 Locking Screw — Trimed, INC.
- 2.7 Locking Screw — Trimed, INC.
- 2.7 Locking Screw — Trimed, INC.
- 2.7 Locking Screw — Trimed, INC.
- 2.7 Locking Screw — Trimed, INC.
- 3.5 Locking Screw — Trimed, INC.
- 3.5 Locking Screw — 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 |
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Manufacturer
- Manufacturer
- Trimed, INC.
Sources (1)
- FDA UDI 189ddfa1-955e-40aa-9e4c-59a84908afd1 37 fields · synced May 31, 2026