K230764 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 (Logan, US). The FDA issued a Cleared decision on April 18, 2023, 29 days after receiving the submission on March 20, 2023.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3030.
| 510(k) Number | K230764 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 20, 2023 |
| Decision Date | April 18, 2023 |
| Days to Decision | 29 days |
| Submission Type | Special |
| 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 |