K031280 is an FDA 510(k) clearance for the ULTRA-DRIVE 3. This device is classified as a Instrument, Surgical, Sonic And Accessory/attachment (Class II - Special Controls, product code JDX).
Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on September 22, 2003, 153 days after receiving the submission on April 22, 2003.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 888.4580.
| 510(k) Number | K031280 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 22, 2003 |
| Decision Date | September 22, 2003 |
| Days to Decision | 153 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | JDX — Instrument, Surgical, Sonic And Accessory/attachment |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.4580 |