K100761 is an FDA 510(k) clearance for the BIOPRO POLAR HEAD. This device is classified as a Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented (Class II - Special Controls, product code KWY).
Submitted by Biopro, Inc. (Port Huron, US). The FDA issued a Cleared decision on December 3, 2010, 261 days after receiving the submission on March 17, 2010.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3390.
| 510(k) Number | K100761 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 17, 2010 |
| Decision Date | December 03, 2010 |
| Days to Decision | 261 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | KWY — Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3390 |