K231162 is an FDA 510(k) clearance for the ROSA Hip System. This device is classified as a System, Image Processing, Radiological (Class II - Special Controls, product code LLZ).
Submitted by Orthosoft Inc. (d/b/a) Zimmer CAS (Montreal, CA). The FDA issued a Cleared decision on May 23, 2023, 29 days after receiving the submission on April 24, 2023.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.2050.
| 510(k) Number | K231162 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 24, 2023 |
| Decision Date | May 23, 2023 |
| Days to Decision | 29 days |
| Submission Type | Special |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | LLZ — System, Image Processing, Radiological |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.2050 |