K233567 is an FDA 510(k) clearance for the OsteoCoil™ Nitinol Compression System (Multiple Component PNs). This device is classified as a Screw, Fixation, Bone (Class II - Special Controls, product code HWC).
Submitted by Flower Orthopedics Corporation Dba Conventus Flower Ortho (Horsham, US). The FDA issued a Cleared decision on November 22, 2024, 382 days after receiving the submission on November 6, 2023.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3040.
| 510(k) Number | K233567 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 06, 2023 |
| Decision Date | November 22, 2024 |
| Days to Decision | 382 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | HWC - Screw, Fixation, Bone |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3040 |