Identity
- Trade Name
- Titan Humeral Resurfacing Arthroplasty FDA UDI
- Generic Name
- Humeral head prosthesis trial, reusable FDA UDI
- Device Name
- HRA TRIAL SZ. 48/17 FDA UDI
- Model / Reference
- TRL-900-48/17 FDA UDI
- Description
- HRA TRIAL SZ. 48/17 FDA UDI
Identifiers
- Catalog Number
- TRL-900-48/17 FDA UDI
- Primary DI / UDI-DI
- 00885556837498 FDA UDI
- 510(k) Number
- K062861 FDA UDI
- FDA Product Code
- HSD FDA UDI
- GMDN Term
- Humeral head prosthesis trial, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3690 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: Humeral head prosthesis trial, reusable
Titan Humeral Resurfacing Arthroplasty by Smith & Nephew, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Humeral head prosthesis trial, reusable.
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Cleared under the same submission
K062861 also covers:
- Integra® — Ascension Orthopedics, Inc.
- Integra® — Ascension Orthopedics, Inc.
- Integra® — Ascension Orthopedics, Inc.
- Integra® — Ascension Orthopedics, Inc.
- Integra® — Ascension Orthopedics, Inc.
- Integra® — Ascension Orthopedics, Inc.
- Integra® — Ascension Orthopedics, Inc.
- Integra® — Ascension Orthopedics, Inc.
- Integra® — Ascension Orthopedics, Inc.
- Integra® — Ascension Orthopedics, Inc.
- Integra® — Ascension Orthopedics, Inc.
- Integra® — Ascension 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
- Smith & Nephew, Inc.
Sources (1)
- FDA UDI 551b31f4-0655-46c8-a410-e5b75c2cba3e 36 fields · synced Jun 6, 2026