The following data is part of a premarket notification filed by Arthrex, Inc. with the FDA for Arthrex Pec Repair Button, Arthrex Large Pec Button, Arthrex Biceps Button, Arthrex Proximal Biceps Button.
| Device ID | K123341 |
| 510k Number | K123341 |
| Device Name: | ARTHREX PEC REPAIR BUTTON, ARTHREX LARGE PEC BUTTON, ARTHREX BICEPS BUTTON, ARTHREX PROXIMAL BICEPS BUTTON |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | ARTHREX, INC. 1370 Creekside Blvd Naples, FL 34108 |
| Contact | Christina Flores |
| Correspondent | Christina Flores ARTHREX, INC. 1370 Creekside Blvd Naples, FL 34108 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-10-31 |
| Decision Date | 2012-12-21 |
| Summary: | summary |