K000764 is an FDA 510(k) clearance for the PEDIATRIC FIXATION RODS. This device is classified as a Nail, Fixation, Bone (Class II - Special Controls, product code JDS).
Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on April 6, 2000, 28 days after receiving the submission on March 9, 2000.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3030.
| 510(k) Number | K000764 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 09, 2000 |
| Decision Date | April 06, 2000 |
| Days to Decision | 28 days |
| Submission Type | Special |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | JDS — Nail, Fixation, Bone |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3030 |