K101837 is an FDA 510(k) clearance for the ACL TIGHTROPE DOUBLE BUNDLE. This device is classified as a Pin, Fixation, Smooth (Class II - Special Controls, product code HTY).
Submitted by Arthrex, Inc. (Naples, US). The FDA issued a Cleared decision on December 28, 2010, 180 days after receiving the submission on July 1, 2010.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3040.
| 510(k) Number | K101837 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 01, 2010 |
| Decision Date | December 28, 2010 |
| Days to Decision | 180 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | HTY — Pin, Fixation, Smooth |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3040 |