Identity
- Trade Name
- THP™ Hip Fracture Plating System FDA UDI
- Generic Name
- Fluted surgical drill bit, single-use FDA UDI
- Model / Reference
- 14-451527 FDA UDI
Identifiers
- Catalog Number
- 14-451527 FDA UDI
- Primary DI / UDI-DI
- 00887868164576 FDA UDI
- FDA Product Code
- HWC FDA UDIKTT FDA UDIJDO FDA UDI
- GMDN Term
- Fluted surgical drill bit, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3040 FDA UDI888.3030 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Fluted surgical drill bit, single-use
THP™ Hip Fracture Plating System by Biomet Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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.
- 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.
- TSP HIP FX PLATING SYSTEM4.5MM CORTICAL LOCKING SCREW — Biomet Orthopedics, Inc.
K173826 also covers:
- THP™ HIP FRACTURE PLATING SYSTEM5.0MM CORTICAL LOCKING SCREW — Biomet Orthopedics, Inc.
- THP™ HIP FRACTURE PLATING SYSTEM5.0MM CORTICAL LOCKING SCREW — Biomet Orthopedics, Inc.
- THP™ HIP FRACTURE PLATING SYSTEM5.0MM CORTICAL LOCKING SCREW — Biomet Orthopedics, Inc.
- THP™ HIP FRACTURE PLATING SYSTEM5.0MM CORTICAL NON-LOCK SCREW — 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.
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
- Biomet Orthopedics, Inc.
Sources (1)
- FDA UDI f9f5a7d8-a137-4cdb-9955-c1ca23f6748d 35 fields · synced May 30, 2026