The following data is part of a premarket notification filed by Arthrex, Inc. with the FDA for Bio-button 6.5mm, Bio-button 8mm, Model #'s Ar-2236b & Ar-2238b.
| Device ID | K983843 |
| 510k Number | K983843 |
| Device Name: | BIO-BUTTON 6.5MM, BIO-BUTTON 8MM, MODEL #'S AR-2236B & AR-2238B |
| Classification | Fastener, Fixation, Biodegradable, Soft Tissue |
| Applicant | ARTHREX, INC. 2885 SOUTH HORSESHOE DR. Naples, FL 34104 |
| Contact | Scott M Durlacher |
| Correspondent | Scott M Durlacher ARTHREX, INC. 2885 SOUTH HORSESHOE DR. Naples, FL 34104 |
| Product Code | MAI |
| Subsequent Product Code | GAS |
| Subsequent Product Code | KGS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-10-30 |
| Decision Date | 1999-03-12 |
| Summary: | summary |