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Thp™ Hip Fracture Plating System5.0mm Cortical Locking Screw
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- THP™ HIP FRACTURE PLATING SYSTEM5.0MM CORTICAL LOCKING SCREW FDA UDI
- Generic Name
- Fluted surgical drill bit, single-use, non-sterile FDA UDI
- Model / Reference
- 14-454585 FDA UDI
Identifiers
- Catalog Number
- 14-454585 FDA UDI
- Primary DI / UDI-DI
- 00887868165894 FDA UDI
- 510(k) Number
- K173826 FDA UDI
- FDA Product Code
- JDO FDA UDI
- GMDN Term
- Fluted surgical drill bit, single-use, non-sterile 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
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
MR Unsafe FDA UDI
Category: Fluted surgical drill bit, single-use, non-sterile
Thp™ Hip Fracture Plating System5.0mm Cortical Locking Screw by Biomet Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Fluted surgical drill bit, single-use, non-sterile.
- Simpex Drill Bit — SIMPEX MEDICAL, INC. · Class I
- Dynamic Axial Fixator — Orthofix, Inc. · Class II
- Dynamic Axial Fixator — Orthofix, Inc. · Class II
- CURE ACP — MEDITECH SPINE, LLC · Class II
- Simpex Drill Bit — SIMPEX MEDICAL, INC. · Class I
- XtraFix® — Zimmer, Inc. · Class I
- AFT™ Proximal Humerus Fracture Plate System — Shoulder Options, Inc. · Class II
- OsteoMed — Osteomed Corp. · Class II
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 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.
- 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 077792a4-356e-40c4-ab18-0484712034f1 36 fields · synced Jun 8, 2026