K934327 is an FDA 510(k) clearance for the ARTHREX SUTURE ANCHOR SCREW SYSTEM. This device is classified as a Fastener, Fixation, Nondegradable, Soft Tissue (Class II - Special Controls, product code MBI).
Submitted by Arthrex, Inc. (Naples, US). The FDA issued a Cleared decision on September 15, 1995, 742 days after receiving the submission on September 3, 1993.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3040.
| 510(k) Number | K934327 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 03, 1993 |
| Decision Date | September 15, 1995 |
| Days to Decision | 742 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Statement |
| Product Code | MBI — Fastener, Fixation, Nondegradable, Soft Tissue |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3040 |