The following data is part of a premarket notification filed by Arthrex, Inc. with the FDA for Arthrex Bio- Composite Suture Anchors: Bio-composite Pushlock, Bio-composite Tak, Bio-composite Corkscrew.
| Device ID | K071177 |
| 510k Number | K071177 |
| Device Name: | ARTHREX BIO- COMPOSITE SUTURE ANCHORS: BIO-COMPOSITE PUSHLOCK, BIO-COMPOSITE TAK, BIO-COMPOSITE CORKSCREW |
| Classification | Screw, Fixation, Bone |
| Applicant | ARTHREX, INC. 1370 CREEKSIDE BLVD. Naples, FL 34108 -1945 |
| Contact | Mariela Cabarcas |
| Correspondent | Mariela Cabarcas ARTHREX, INC. 1370 CREEKSIDE BLVD. Naples, FL 34108 -1945 |
| Product Code | HWC |
| Subsequent Product Code | JDR |
| Subsequent Product Code | MAI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-04-27 |
| Decision Date | 2007-06-29 |
| Summary: | summary |