Submission Details
| 510(k) Number | K090835 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 27, 2009 |
| Decision Date | June 22, 2009 |
| Days to Decision | 87 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
K090835 is an FDA 510(k) clearance for the CONMED LINVATEC BIO MINI-REVO SUTURE ANCHOR, MODEL C6170CR, a Fastener, Fixation, Biodegradable, Soft Tissue (Class II — Special Controls, product code MAI), submitted by Linvatec Corp. (Largo, US). The FDA issued a Cleared decision on June 22, 2009, 87 days after receiving the submission on March 27, 2009. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.
| 510(k) Number | K090835 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 27, 2009 |
| Decision Date | June 22, 2009 |
| Days to Decision | 87 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 |