K210247 is an FDA 510(k) clearance for the OsteoCentric Integrated Hip Fastener System. This device is classified as a Device, Fixation, Proximal Femoral, Implant (Class II - Special Controls, product code JDO).
Submitted by Osteocentric Technologies D.B.A. Osteocentric Trauma (Logan, US). The FDA issued a Cleared decision on April 30, 2021, 91 days after receiving the submission on January 29, 2021.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3030.
| 510(k) Number | K210247 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 29, 2021 |
| Decision Date | April 30, 2021 |
| Days to Decision | 91 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | JDO - Device, Fixation, Proximal Femoral, Implant |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3030 |