Identity
- Trade Name
- THP™ Hip Fracture Plating System FDA UDI
- Generic Name
- Orthopaedic fixation implant alignment tool FDA UDI
- Model / Reference
- 14-451579 FDA UDI
Identifiers
- Catalog Number
- 14-451579 FDA UDI
- Primary DI / UDI-DI
- 00887868165597 FDA UDI
- 510(k) Number
- K173826 FDA UDI
- FDA Product Code
- JDO FDA UDIKTT FDA UDIHWC FDA UDI
- GMDN Term
- Orthopaedic fixation implant alignment tool FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3030 FDA UDI888.3040 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 fixation implant alignment tool
THP™ Hip Fracture Plating System by Biomet Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic fixation implant alignment tool.
- Flux-C Cervical Interbody — ULRICH MEDICAL USA, INC. · Class II
- EVOS — Smith & Nephew, Inc. · Class II
- “Paonan” Orthopedic Manual Surgical Instrument (Non-Sterile) — Paonan Biotech Co., Ltd. · Class I
- U1™ Hip — UNITED ORTHOPEDIC CORP. · Class I
- U2™ Knee — UNITED ORTHOPEDIC CORP. · Class I
- U-Motion II — UNITED ORTHOPEDIC CORP. · Class I
- Flux-C Cervical Interbody — ULRICH MEDICAL USA, INC. · Class II
- Easyspine — Ldr Spine USA · Class I
Cleared under the same submission
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 |
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Manufacturer
- Manufacturer
- Biomet Orthopedics, Inc.
Sources (1)
- FDA UDI dcf44eb9-7fce-4d22-98d6-dbf9e542c07c 35 fields · synced May 30, 2026