Identity
- Trade Name
- Titan Reverse Shoulder System FDA UDI
- Generic Name
- Reverse shoulder prosthesis base plate FDA UDI
- Device Name
- REVERSE BASEPLATE 25MM FDA UDI
- Model / Reference
- GBP-0960-030-25 FDA UDI
- Description
- REVERSE BASEPLATE 25MM FDA UDI
Identifiers
- Catalog Number
- GBP-0960-030-25 FDA UDI
- Primary DI / UDI-DI
- 00885556863732 FDA UDI
- FDA Product Code
- KWS FDA UDIPHX FDA UDI
- GMDN Term
- Reverse shoulder prosthesis base plate FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3660 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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: Reverse shoulder prosthesis base plate
Titan Reverse Shoulder System by Smith & Nephew, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K130050 also covers:
- Titan™ — Ascension Orthopedics, Inc.
- Titan™ — Ascension Orthopedics, Inc.
- Titan™ — Ascension Orthopedics, Inc.
- Titan™ — Ascension Orthopedics, Inc.
- Titan™ — Ascension Orthopedics, Inc.
- Titan™ — Ascension Orthopedics, Inc.
- Titan™ — Ascension Orthopedics, Inc.
- Titan™ — Ascension Orthopedics, Inc.
- Titan™ — Ascension Orthopedics, Inc.
- Titan™ Reverse Shoulder System — Ascension Orthopedics, Inc.
- Titan™ Reverse Shoulder System — Ascension Orthopedics, Inc.
- Titan™ Reverse Shoulder System — Ascension Orthopedics, Inc.
K161189 also covers:
- Titan Reverse Shoulder System — Smith & Nephew, Inc.
- Titan Reverse Shoulder System — Smith & Nephew, Inc.
- Titan Reverse Shoulder System — Smith & Nephew, Inc.
- Titan Reverse Shoulder System — Smith & Nephew, Inc.
- Titan Reverse Shoulder System — Smith & Nephew, Inc.
- Titan Reverse Shoulder System — Smith & Nephew, Inc.
- Titan Reverse Shoulder System — Smith & Nephew, Inc.
- Titan Reverse Shoulder System — Smith & Nephew, Inc.
- Titan Reverse Shoulder System — Smith & Nephew, Inc.
- Titan Reverse Shoulder System — Smith & Nephew, Inc.
- Titan Reverse Shoulder System — Smith & Nephew, Inc.
- Titan Reverse Shoulder System — Smith & Nephew, Inc.
K173717 also covers:
K213827 also covers:
- Katalyst Biopolar Radial Head System — Smith & Nephew, Inc.
- Katalyst Bipolar Radial Head System — Smith & Nephew, Inc.
- Modular Radial Head (MRH) System — Smith & Nephew, Inc.
- Modular Radial Head (MRH) System — Smith & Nephew, Inc.
- Modular Radial Head (MRH) System — Smith & Nephew, Inc.
- Titan Humeral Resurfacing Arthroplasty — Smith & Nephew, Inc.
- Titan Humeral Resurfacing Arthroplasty — Smith & Nephew, Inc.
- Titan Modular Shoulder System — Smith & Nephew, Inc.
- Titan Modular Shoulder System — Smith & Nephew, Inc.
- Titan Modular Shoulder System 2.5 — Smith & Nephew, Inc.
- Titan Modular Shoulder System 2.5 — Smith & Nephew, Inc.
- Titan Modular Shoulder System 2.5 — Smith & Nephew, 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 786b7693-a890-4aa9-ab3b-8347c7f45121 36 fields · synced Jun 8, 2026