Identity
- Trade Name
- ROSA® Hip FDA UDI
- Generic Name
- Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDI
- Device Name
- ROSA® Offset Cup Inserter Shaft FDA UDI
- Model / Reference
- 20-8060-303-00 FDA UDI
- Description
- ROSA® Offset Cup Inserter Shaft FDA UDI
Identifiers
- Catalog Number
- 20-8060-303-00 FDA UDI
- Primary DI / UDI-DI
- 00887868518546 FDA UDI
- 510(k) Number
- K210998 FDA UDI
- FDA Product Code
- LLZ FDA UDIOLO FDA UDI
- GMDN Term
- Orthopaedic prosthesis implantation positioning instrument, 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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Orthopaedic prosthesis implantation positioning instrument, reusable
ROSA® Hip by Orthosoft Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K210998 also covers:
- ROSA Cup Inserter Adaptor — Orthosoft Inc
- ROSA Cup Inserter Handle — Orthosoft Inc
- ROSA Cup Inserter Screw — Orthosoft Inc
- ROSA Hip Software — Orthosoft Inc
- ROSA Quick Connect Interface — Orthosoft Inc
- ROSA Quick Connect Sleeve — Orthosoft Inc
- ROSA Straight Cup Inserter Shaft — Orthosoft Inc
- ROSA Tablet — Orthosoft Inc
- Tablet Battery — Orthosoft Inc
- Tablet Battery Bay — Orthosoft Inc
- Tablet Power Cord — 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 84ac7f45-28dd-49f0-ae82-021e6d64d3c5 35 fields · synced Jun 8, 2026