Identity
- Trade Name
- TSP HIP FX PLATING SYSTEMTROCAR, 4.5MM SCREW FDA UDI
- Generic Name
- Orthopaedic implantation sleeve, reusable FDA UDI
- Model / Reference
- 14-451536 FDA UDI
Identifiers
- Catalog Number
- 14-451536 FDA UDI
- Primary DI / UDI-DI
- 00887868129971 FDA UDI
- 510(k) Number
- K140018 FDA UDI
- FDA Product Code
- KTT FDA UDIJDO FDA UDI
- GMDN Term
- Orthopaedic implantation sleeve, reusable 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
No
FDA UDI
Implantable
No
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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Orthopaedic implantation sleeve, reusable
Tsp Hip Fx Plating Systemtrocar, 4.5mm Screw by Biomet Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Orthopaedic implantation sleeve, reusable.
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Cleared under the same submission
K140018 also covers:
- THP™ Hip Fracture Plating System — Biomet Orthopedics, Inc.
- THP™ Hip Fracture Plating System — Biomet Orthopedics, Inc.
- THP™ Hip Fracture Plating System — Biomet Orthopedics, Inc.
- THP™ Hip Fracture Plating System — Biomet Orthopedics, Inc.
- THP™ Hip Fracture Plating System — Biomet Orthopedics, Inc.
- THP™ Hip Fracture Plating System — Biomet Orthopedics, Inc.
- THP™ Hip Fracture Plating System — Biomet Orthopedics, Inc.
- THP™ Hip Fracture Plating System — Biomet Orthopedics, Inc.
- THP™ Hip Fracture Plating System — Biomet Orthopedics, Inc.
- TSP HIP FX PLATING SYSTEM3.0MM GUIDE WIRE — Biomet Orthopedics, Inc.
- TSP HIP FX PLATING SYSTEM3.5MM HEX DRIVER, NECK SHAFT — Biomet Orthopedics, Inc.
- TSP HIP FX PLATING SYSTEM4.5MM CORTICAL LOCKING SCREW — Biomet Orthopedics, 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
- Biomet Orthopedics, Inc.
Sources (1)
- FDA UDI d697663c-098f-46db-94dd-bb2cc6a3e0cf 36 fields · synced Jun 1, 2026