Identity
- Trade Name
- Titan™ FDA UDI
- Generic Name
- Uncoated shoulder humeral stem prosthesis FDA UDI
- Device Name
- Total Shoulder System Cemented Long Stem, 14 x 165mm FDA UDI
- Model / Reference
- S095002514165 FDA UDI
- Description
- Total Shoulder System Cemented Long Stem, 14 x 165mm FDA UDI
Identifiers
- Catalog Number
- STEM-0950-025-14165 FDA UDI
- Primary DI / UDI-DI
- 10381780364207 FDA UDI
- 510(k) Number
- K142413 FDA UDI
- FDA Product Code
- KWS FDA UDI
- GMDN Term
- Uncoated shoulder humeral stem prosthesis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3660 FDA UDI
- Commercial Distribution
- Not 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
Dimensions & Sizes
- Size
- Length — 165 Millimeter FDA UDIOuter Diameter — 14 Millimeter FDA UDI
Titan™ by Ascension Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K142413 also covers:
- Integra® — Ascension Orthopedics, Inc.
- Titan™ — Ascension Orthopedics, Inc.
- Titan™ — Ascension Orthopedics, Inc.
- Titan™ — Ascension Orthopedics, Inc.
- Titan™ Total Shoulder System — Ascension Orthopedics, Inc.
- Titan™ Total Shoulder System — Ascension Orthopedics, Inc.
- Titan™ Total Shoulder System — Ascension Orthopedics, Inc.
- Titan™ Total Shoulder System — Ascension Orthopedics, Inc.
- Titan™ Total Shoulder System — Ascension Orthopedics, Inc.
- Titan™ Total Shoulder System — Ascension Orthopedics, Inc.
- Titan™ Total Shoulder System — Ascension Orthopedics, Inc.
- Titan™ Total Shoulder System — 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
- Ascension Orthopedics, Inc.
Sources (1)
- FDA UDI 5c95ed51-1b2a-4a5c-a23a-8d088c51c739 39 fields · synced Jun 6, 2026