K953264 is an FDA 510(k) clearance for the QUESTUS POLYESTER SUTURE SOFT TISSUE ANCHOR SYSTEM. This device is classified as a Fastener, Fixation, Nondegradable, Soft Tissue (Class II - Special Controls, product code MBI).
Submitted by Wrightmedicaltechnologyinc (Arlington, US). The FDA issued a Cleared decision on October 20, 1995, 99 days after receiving the submission on July 13, 1995.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3040.
| 510(k) Number | K953264 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - NSE Converted (SN) |
| Date Received | July 13, 1995 |
| Decision Date | October 20, 1995 |
| Days to Decision | 99 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | — |
| Product Code | MBI — Fastener, Fixation, Nondegradable, Soft Tissue |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3040 |