K080685 is an FDA 510(k) clearance for the HIPLOC COMPRESSION HIP SCREW. This device is classified as a Device, Fixation, Proximal Femoral, Implant (Class II - Special Controls, product code JDO).
Submitted by Biomet Manufacturing, Inc. (Warsaw,, US). The FDA issued a Cleared decision on August 15, 2008, 157 days after receiving the submission on March 11, 2008.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3030.
| 510(k) Number | K080685 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 11, 2008 |
| Decision Date | August 15, 2008 |
| Days to Decision | 157 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 |