The following data is part of a premarket notification filed by Arthrex, Inc. with the FDA for Arthrex Biocomposite Transfix.
| Device ID | K112040 |
| 510k Number | K112040 |
| Device Name: | ARTHREX BIOCOMPOSITE TRANSFIX |
| Classification | Fastener, Fixation, Biodegradable, Soft Tissue |
| Applicant | ARTHREX, INC. 1370 CREEKSIDE BLVD. Naples, FL 34108 -1945 |
| Contact | Sally Foust |
| Correspondent | Sally Foust 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 | 2011-07-18 |
| Decision Date | 2011-12-15 |
| Summary: | summary |