Identity
- Trade Name
- Titan™ FDA UDI
- Generic Name
- Orthopaedic reamer guide FDA UDI
- Device Name
- Titan™ Reverse Shoulder System The humeral reamer guide body is used to assist with preparation and placement of the trials and implants in the reverse shoulder system. FDA UDI
- Model / Reference
- RGB096008STD FDA UDI
- Description
- Titan™ Reverse Shoulder System The humeral reamer guide body is used to assist with preparation and placement of the trials and implants in the reverse shoulder system. FDA UDI
Identifiers
- Catalog Number
- RGB-0960-08STD FDA UDI
- Primary DI / UDI-DI
- 10381780247029 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Orthopaedic reamer guide FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Orthopaedic reamer guide
Titan™ by Ascension Orthopedics, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic reamer guide.
- JOURNEY — Smith & Nephew, Inc. · Class II
- Revision Knee System — SHALBY ADVANCED TECHNOLOGIES, INC. · Class I
- Cone Reamer Guide — TOTAL JOINT ORTHOPEDICS, INC. · Class I
- SMR Shoulder — Limacorporate · Class II
- PRIMA TT Glenoid — Limacorporate · Class II
- Titan Reverse Shoulder System — Smith & Nephew, Inc. · Class I
- MAXIM RESECTION DISTAL — Biomet Orthopedics, Inc. · Class I
- Arthrex® — Arthrex, Inc. · Class I
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 I | Pending data |
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Manufacturer
- Manufacturer
- Ascension Orthopedics, Inc.
Sources (1)
- FDA UDI 396b7b83-0e5d-4f5e-92d4-6710d5f15750 37 fields · synced May 31, 2026