Identity
- Trade Name
- ROSA® KNEE SOFTWARE FDA UDI
- Generic Name
- Robotic surgical navigation system application software FDA UDI
- Model / Reference
- 20-8020-130-01 FDA UDI
Identifiers
- Catalog Number
- 20-8020-130-01 FDA UDI
- Primary DI / UDI-DI
- 00889024511330 FDA UDI
- 510(k) Number
- K182964 FDA UDI
- FDA Product Code
- OLO FDA UDI
- GMDN Term
- Robotic surgical navigation system application software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.4560 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
No
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
Category: Robotic surgical navigation system application software
Rosa® Knee Software by Orthosoft Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Robotic surgical navigation system application software.
- 360CAS — KICO KNEE INNOVATION COMPANY PTY LIMITED · Class II
- 360CAS — KICO KNEE INNOVATION COMPANY PTY LIMITED · Class II
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- OMNIBotics — OMNIlife science, Inc. · Class II
- ORTHOMAP — Stryker Leibinger · Class II
- 360CAS — KICO KNEE INNOVATION COMPANY PTY LIMITED · Class II
- Mako — MAKO Surgical Corp. · Class II
- PROFESS — Stryker Leibinger · Class II
Cleared under the same submission
K182964 also covers:
- CLINICAL PC — Orthosoft Inc
- ROSA® — Orthosoft Inc
- ROSA® — Orthosoft Inc
- ROSA® KNEE SOFTWARE UPGRADE — Orthosoft Inc
- ROSA® Nexgen TKA cut guide - B — Orthosoft Inc
- ROSA® Nexgen TKA cut guide -A — Orthosoft Inc
- ROSA® Persona TKA cut guide - A — Orthosoft Inc
- ROSA® Persona TKA cut guide - B — Orthosoft Inc
- ROSA® Recon — Orthosoft Inc
- ROSA® Recon Platform — Orthosoft Inc
- ROSA® Vanguard TKA cut guide - A — Orthosoft Inc
- ROSA® Vanguard TKA cut guide - B — 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 43eef368-1f6e-4a69-94be-c9da28a47d9e 35 fields · synced Jun 8, 2026