K982095 is an FDA 510(k) clearance for the LACTOSORB MENISCAL REPAIR DEVICE. This device is classified as a Fastener, Fixation, Biodegradable, Soft Tissue (Class II - Special Controls, product code MAI).
Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on January 27, 1999, 226 days after receiving the submission on June 15, 1998.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3030.
| 510(k) Number | K982095 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 15, 1998 |
| Decision Date | January 27, 1999 |
| Days to Decision | 226 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | MAI — Fastener, Fixation, Biodegradable, Soft Tissue |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3030 |