K011172 is an FDA 510(k) clearance for the ARTHREX BIO-TRANSFIX. This device is classified as a Staple, Absorbable (Class II - Special Controls, product code MNU).
Submitted by Arthrex, Inc. (Naples, US). The FDA issued a Cleared decision on June 19, 2001, 63 days after receiving the submission on April 17, 2001.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3030.
| 510(k) Number | K011172 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 17, 2001 |
| Decision Date | June 19, 2001 |
| Days to Decision | 63 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | MNU — Staple, Absorbable |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3030 |