The following data is part of a premarket notification filed by Arthrex, Inc. with the FDA for Bio-fastak Suture Anchor, Model Ar-1324b.
| Device ID | K000506 |
| 510k Number | K000506 |
| Device Name: | BIO-FASTAK SUTURE ANCHOR, MODEL AR-1324B |
| Classification | Fastener, Fixation, Biodegradable, Soft Tissue |
| Applicant | ARTHREX, INC. 2885 SOUTH HORSESHOE DR. Naples, FL 34104 |
| Contact | Vernon Brown |
| Correspondent | Vernon Brown ARTHREX, INC. 2885 SOUTH HORSESHOE DR. Naples, FL 34104 |
| Product Code | MAI |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-02-15 |
| Decision Date | 2000-05-01 |
| Summary: | summary |