Identity
- Trade Name
- Titan™ FDA UDI
- Generic Name
- Shoulder prosthesis screw FDA UDI
- Device Name
- RSS 4.5mm Star Screw and Cap; 45mm Length FDA UDI
- Model / Reference
- SCW-0961-046-45 FDA UDI
- Description
- RSS 4.5mm Star Screw and Cap; 45mm Length FDA UDI
Identifiers
- Catalog Number
- SCW-0961-046-45 FDA UDI
- Primary DI / UDI-DI
- 10381780467731 FDA UDI
- 510(k) Number
- K181999 FDA UDI
- FDA Product Code
- PHX FDA UDI
- GMDN Term
- Shoulder prosthesis screw 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
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
Dimensions & Sizes
- Size
- Length — 45 Millimeter FDA UDI
Category: Shoulder prosthesis screw
Titan™ by Ascension Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Shoulder prosthesis screw.
- Comprehensive Reverse Shoulder — Biomet Orthopedics, Inc. · Class II
- COMPREHENSIVE SRS — Biomet Orthopedics, Inc. · Class II
- COMPREHENSIVE REVERSE SHOULDER — Biomet Orthopedics, Inc. · Class II
- Equinoxe — Exactech, Inc. · Class II
- Equinoxe — Exactech, Inc. · Class II
- Humelock II Cementless Shoulder System — FX SOLUTIONS · Class II
- HemiCAP® — ARTHROSURFACE INCORPORATED · Class II
- Comprehensive Reverse Shoulder — Biomet Orthopedics, Inc. · Class II
Cleared under the same submission
K181999 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™ — Ascension Orthopedics, Inc.
- Titan™ — Ascension Orthopedics, Inc.
- Titan™ — 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 edcb3950-80aa-438a-a1ac-6ded47c8d7aa 38 fields · synced May 31, 2026