K810258 is an FDA 510(k) clearance for the PROXIMAL FERMORAL HIP REPLACEMENT. This device is classified as a Device, Fixation, Proximal Femoral, Implant (Class II - Special Controls, product code JDO).
Submitted by Biomet, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 5, 1981, 34 days after receiving the submission on January 30, 1981.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3030.
| 510(k) Number | K810258 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 30, 1981 |
| Decision Date | March 05, 1981 |
| Days to Decision | 34 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | — |
| Product Code | JDO — Device, Fixation, Proximal Femoral, Implant |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3030 |