The following data is part of a premarket notification filed by Arthrex, Inc. with the FDA for Arthrex Bio-transfix.
| Device ID | K011172 |
| 510k Number | K011172 |
| Device Name: | ARTHREX BIO-TRANSFIX |
| Classification | Staple, Absorbable |
| 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 | MNU |
| Subsequent Product Code | HTY |
| Subsequent Product Code | JDR |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-04-17 |
| Decision Date | 2001-06-19 |
| Summary: | summary |