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Thp™ Hip Fracture Plating System5.0mm Cortical Non-Lock Screw
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- THP™ HIP FRACTURE PLATING SYSTEM5.0MM CORTICAL NON-LOCK SCREW FDA UDI
- Generic Name
- Orthopaedic bone screw, non-bioabsorbable, sterile FDA UDI
- Model / Reference
- 14-455590 FDA UDI
Identifiers
- Catalog Number
- 14-455590 FDA UDI
- Primary DI / UDI-DI
- 00887868166211 FDA UDI
- 510(k) Number
- K173826 FDA UDI
- FDA Product Code
- JDO FDA UDI
- GMDN Term
- Orthopaedic bone screw, non-bioabsorbable, 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: Orthopaedic bone screw, non-bioabsorbable, sterile
Thp™ Hip Fracture Plating System5.0mm Cortical Non-Lock Screw by Biomet Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Orthopaedic bone screw, non-bioabsorbable, sterile.
- EPS Plating System Screw — GRAMERCY EXTREMITY ORTHOPEDICS, LLC. · Class II
- Peri-Loc — Smith & Nephew, Inc. · Class II
- Cortical Screw 2.5mm x 24mm Sterile — BIOPRO, INC. · Class II
- OsteoMed — Osteomed Corp. · Class II
- 3.5mm x 10mm Ti Cortical Screw — WISHBONE MEDICAL INC. · Class II
- primaLOK FF — Wenzel Spine · U
- Libertas — MAXX ORTHOPEDICS INC. · Class II
- Exactech — Exactech, Inc. · 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 LOCKING 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 dfa47a94-29cd-40fa-accf-1598a8ec3652 36 fields · synced May 30, 2026