K012572 is an FDA 510(k) clearance for the SOFT TISSUE SCREW AND WASHER. This device is classified as a Screw, Fixation, Bone (Class II - Special Controls, product code HWC).
Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on December 3, 2001, 116 days after receiving the submission on August 9, 2001.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3040.
| 510(k) Number | K012572 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 09, 2001 |
| Decision Date | December 03, 2001 |
| Days to Decision | 116 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | HWC — Screw, Fixation, Bone |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3040 |