The following data is part of a premarket notification filed by Arthrex, Inc. with the FDA for Arthrex Bio-post And Washer.
| Device ID | K011495 |
| 510k Number | K011495 |
| Device Name: | ARTHREX BIO-POST AND WASHER |
| Classification | Fastener, Fixation, Biodegradable, Soft Tissue |
| Applicant | ARTHREX, INC. 2885 SOUTH HORSESHOE DR. Naples, FL 34104 |
| Contact | Ann Waterhouse |
| Correspondent | Ann Waterhouse ARTHREX, INC. 2885 SOUTH HORSESHOE DR. Naples, FL 34104 |
| Product Code | MAI |
| Subsequent Product Code | HWC |
| Subsequent Product Code | JDR |
| Subsequent Product Code | MNU |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-05-15 |
| Decision Date | 2001-08-01 |
| Summary: | summary |