K222912 is an FDA 510(k) clearance for the c1Trac. This device is classified as a Equipment, Traction, Powered (Class II - Special Controls, product code ITH).
Submitted by Zimmer Medizinsysteme GmbH (Neu-Ulm, DE). The FDA issued a Cleared decision on May 16, 2023, 232 days after receiving the submission on September 26, 2022.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5900.
| 510(k) Number | K222912 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 26, 2022 |
| Decision Date | May 16, 2023 |
| Days to Decision | 232 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
| Product Code | ITH - Equipment, Traction, Powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5900 |