K211843 is an FDA 510(k) clearance for the PolyLock Plating System. This device is classified as a Plate, Fixation, Bone (Class II - Special Controls, product code HRS).
Submitted by Fusion Orthopedics (Mesa, US). The FDA issued a Cleared decision on March 4, 2022, 262 days after receiving the submission on June 15, 2021.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3030.
| 510(k) Number | K211843 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 15, 2021 |
| Decision Date | March 04, 2022 |
| Days to Decision | 262 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | HRS — Plate, Fixation, Bone |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3030 |