K003131 is an FDA 510(k) clearance for the MODIFICATION TO: RADIOLUCENT COLLES FRACTURE KIT. This device is classified as a Pin, Fixation, Threaded (Class II - Special Controls, product code JDW).
Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on November 2, 2000, 27 days after receiving the submission on October 6, 2000.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3040.
| 510(k) Number | K003131 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 06, 2000 |
| Decision Date | November 02, 2000 |
| Days to Decision | 27 days |
| Submission Type | Special |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | JDW — Pin, Fixation, Threaded |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3040 |