The following data is part of a premarket notification filed by Arthrex, Inc. with the FDA for Arthrex Bio-composite Suture Anchors: Arthrex Bio-composite Pushlock, Bio-composite Tak And Bio-composite Corkscrew.
| Device ID | K082810 |
| 510k Number | K082810 |
| Device Name: | ARTHREX BIO-COMPOSITE SUTURE ANCHORS: ARTHREX BIO-COMPOSITE PUSHLOCK, BIO-COMPOSITE TAK AND BIO-COMPOSITE CORKSCREW |
| Classification | Fastener, Fixation, Biodegradable, Soft Tissue |
| Applicant | ARTHREX, INC. 1370 CREEKSIDE BLVD. Naples, FL 34108 -1945 |
| Contact | Nancy Hoft |
| Correspondent | Nancy Hoft ARTHREX, INC. 1370 CREEKSIDE BLVD. Naples, FL 34108 -1945 |
| Product Code | MAI |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-24 |
| Decision Date | 2009-01-23 |
| Summary: | summary |