K201219 is an FDA 510(k) clearance for the Biocore9 Femoral Head Resurfacing Component. This device is classified as a Prosthesis, Hip, Femoral, Resurfacing (Class II - Special Controls, product code KXA).
Submitted by Biocore9, LLC (Whippany, US). The FDA issued a Cleared decision on January 19, 2021, 258 days after receiving the submission on May 6, 2020.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3400.
| 510(k) Number | K201219 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 06, 2020 |
| Decision Date | January 19, 2021 |
| Days to Decision | 258 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | KXA - Prosthesis, Hip, Femoral, Resurfacing |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3400 |