Identity
- Trade Name
- Titan™ FDA UDI
- Generic Name
- Humeral body prosthesis trial FDA UDI
- Device Name
- The Fracture Body Trial is used to evaluate the size and fit of the implant. FDA UDI
- Model / Reference
- T95002008STD FDA UDI
- Description
- The Fracture Body Trial is used to evaluate the size and fit of the implant. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10381780124238 FDA UDI
- 510(k) Number
- K142413 FDA UDI
- FDA Product Code
- HSD FDA UDIKWS FDA UDI
- GMDN Term
- Humeral body prosthesis trial FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3690 FDA UDI888.3660 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 body prosthesis trial
Titan™ by Ascension Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Humeral body prosthesis trial.
- Titan Modular Shoulder System — Smith & Nephew, Inc. · Class I
- Equinoxe — Exactech, Inc. · Class II
- SMR Shoulder — Limacorporate · Class II
- Comprehensive Segmental Revision System (SRS) — Biomet Orthopedics, Inc. · Class II
- Equinoxe — Exactech, Inc. · Class I
- Equinoxe — Exactech, Inc. · Class I
- Arthrex® — Arthrex, Inc. · Class I
- SMR Shoulder — Limacorporate · Class II
Cleared under the same submission
K142413 also covers:
- Integra® — 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.
- 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 7b0770d0-69e9-4794-a2c6-e8355f6f5e75 37 fields · synced Jun 1, 2026