The following data is part of a premarket notification filed by Arthrex, Inc. with the FDA for Fastak Suture Anchor.
| Device ID | K960516 |
| 510k Number | K960516 |
| Device Name: | FASTAK SUTURE ANCHOR |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | ARTHREX, INC. 3050 NORTH HORSESHOE DR., SUITE 200 Naples, FL 33942 |
| Contact | Scott M Durlacher |
| Correspondent | Scott M Durlacher ARTHREX, INC. 3050 NORTH HORSESHOE DR., SUITE 200 Naples, FL 33942 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-02-05 |
| Decision Date | 1996-04-18 |
| Summary: | summary |