K043248 is an FDA 510(k) clearance for the TIGHTROPE SYNDESMOSIS REPAIR KIT, TITANIUM, MODEL AR-8920DS. This device is classified as a Washer, Bolt Nut (Class II - Special Controls, product code HTN).
Submitted by Arthrex, Inc. (Naples, US). The FDA issued a Cleared decision on February 16, 2005, 85 days after receiving the submission on November 23, 2004.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3030.
| 510(k) Number | K043248 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 23, 2004 |
| Decision Date | February 16, 2005 |
| Days to Decision | 85 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | HTN — Washer, Bolt Nut |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3030 |