Identity
- Trade Name
- ROSA® Shoulder FDA UDI
- Generic Name
- Joint prosthesis implantation kit, reusable FDA UDI
- Model / Reference
- 20-8087-131-00 FDA UDI
Identifiers
- Catalog Number
- 20808713100 FDA UDI
- Primary DI / UDI-DI
- 00887868575150 FDA UDI
- 510(k) Number
- K233199 FDA UDI
- FDA Product Code
- LLZ FDA UDIOLO FDA UDI
- GMDN Term
- Joint prosthesis implantation kit, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.2050 FDA UDI882.4560 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: Joint prosthesis implantation kit, reusable
ROSA® Shoulder by Orthosoft Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Joint prosthesis implantation kit, reusable.
- Initia Total Hip System — Kyocera Corporation · Class II
- PROPHECY — MicroPort Orthopedics Inc. · Class II
- Cadence Total Ankle System — Smith & Nephew, Inc. · Class I
- IMPLANT PARTNERS™ — MicroPort Orthopedics Inc. · Class I
- Evolution — MicroPort Orthopedics Inc. · Class II
- GUARDIAN® — MicroPort Orthopedics Inc. · Class I
- ADVANCE® — MicroPort Orthopedics Inc. · Class I
- PROPHECY — MicroPort Orthopedics Inc. · Class II
Cleared under the same submission
K233199 also covers:
- ROSA® Shoulder — Orthosoft Inc
- ROSA® Shoulder — Orthosoft Inc
- ROSA® Shoulder — Orthosoft Inc
- ROSA® Shoulder — Orthosoft Inc
- ROSA® Shoulder — Orthosoft Inc
- ROSA® Shoulder — Orthosoft Inc
- ROSA® Shoulder — Orthosoft Inc
- ROSA® Shoulder — Orthosoft Inc
- ROSA® Shoulder — Orthosoft Inc
- ROSA® Shoulder — Orthosoft Inc
- ROSA® Shoulder — Orthosoft Inc
- ROSA® Shoulder — Orthosoft 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
- Orthosoft Inc
Sources (1)
- FDA UDI 694e207a-87ce-4d1f-b378-84d6655ff0a3 35 fields · synced May 30, 2026