The following data is part of a premarket notification filed by Arthrex, Inc. with the FDA for Arthrex Biocomposite Suturetak.
| Device ID | K110660 |
| 510k Number | K110660 |
| Device Name: | ARTHREX BIOCOMPOSITE SUTURETAK |
| Classification | Fastener, Fixation, Biodegradable, Soft Tissue |
| Applicant | ARTHREX, INC. 1370 CREEKSIDE BLVD. Naples, FL 34108 -1945 |
| Contact | Courtney Smith |
| Correspondent | Courtney Smith ARTHREX, INC. 1370 CREEKSIDE BLVD. Naples, FL 34108 -1945 |
| Product Code | MAI |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-03-07 |
| Decision Date | 2011-03-31 |
| Summary: | summary |