The following data is part of a premarket notification filed by Arthrex, Inc. with the FDA for Bio-absorbable Corkscrew Model Ar-1920b.
| Device ID | K003227 |
| 510k Number | K003227 |
| Device Name: | BIO-ABSORBABLE CORKSCREW MODEL AR-1920B |
| 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 |
| Subsequent Product Code | GAP |
| Subsequent Product Code | HWC |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-10-16 |
| Decision Date | 2001-01-08 |