Identity
- Trade Name
- Titan™ Total Shoulder System FDA UDI
- Generic Name
- Surgical soft-tissue manipulation forceps, alligator, reusable FDA UDI
- Device Name
- The Titan Modular Total Shoulder Humeral Head has a centric articulating surface. The humeral head may articulate against the natural glenoid bone, if it is of sufficient quality, or against the polyethylene cemented glenoid bone. It is intended for optimal osteotomy coverage and soft tissue balancing. FDA UDI
- Model / Reference
- M9200104614C FDA UDI
- Description
- The Titan Modular Total Shoulder Humeral Head has a centric articulating surface. The humeral head may articulate against the natural glenoid bone, if it is of sufficient quality, or against the polyethylene cemented glenoid bone. It is intended for optimal osteotomy coverage and soft tissue balancing. FDA UDI
Identifiers
- Catalog Number
- MHH-0920-010-4614C FDA UDI
- Primary DI / UDI-DI
- 10381780120315 FDA UDI
- 510(k) Number
- K142413 FDA UDI
- FDA Product Code
- KWS FDA UDIHSD FDA UDI
- GMDN Term
- Surgical soft-tissue manipulation forceps, alligator, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3660 FDA UDI888.3690 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
Category: Surgical soft-tissue manipulation forceps, alligator, reusable
Titan™ Total Shoulder System by Ascension Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical soft-tissue manipulation forceps, alligator, reusable.
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- Integra® Miltex® — Integra LifeSciences Production Corporation · Class I
- Symmetry Goodhill — SYMMETRY SURGICAL INC. · Class I
- JEDMED — JEDMED Instrument Company · Class I
- BOSS Instruments — Boss Instruments, Ltd. · Class I
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- Symmetry Jako — SYMMETRY SURGICAL INC. · Class I
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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 2d1eb25e-f94e-47c8-af88-f6e9f5bc1ace 38 fields · synced Jun 6, 2026