K220659 is an FDA 510(k) clearance for the AUTOBAHN(R) EVO Femoral Nails. This device is classified as a Rod, Fixation, Intramedullary And Accessories (Class II - Special Controls, product code HSB).
Submitted by Globus Medical, Inc. (Audubon, US). The FDA issued a Cleared decision on September 9, 2022, 186 days after receiving the submission on March 7, 2022.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3020.
| 510(k) Number | K220659 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 07, 2022 |
| Decision Date | September 09, 2022 |
| Days to Decision | 186 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | HSB — Rod, Fixation, Intramedullary And Accessories |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3020 |