The following data is part of a premarket notification filed by Arthrex, Inc. with the FDA for Fastak Suture Anchor (11.7mm)/(7.5mm).
| Device ID | K971723 |
| 510k Number | K971723 |
| Device Name: | FASTAK SUTURE ANCHOR (11.7MM)/(7.5MM) |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | ARTHREX, INC. 2885 SOUTH HORSESHOE DR. Naples, FL 34104 |
| Contact | Scott M Durlacher |
| Correspondent | Scott M Durlacher ARTHREX, INC. 2885 SOUTH HORSESHOE DR. Naples, FL 34104 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-05-09 |
| Decision Date | 1997-07-30 |
| Summary: | summary |