K011007 is an FDA 510(k) clearance for the TENODESIS SCREW, 5.5 MM, MODEL AR-1350-55. This device is classified as a Fastener, Fixation, Nondegradable, Soft Tissue (Class II - Special Controls, product code MBI).
Submitted by Arthrex, Inc. (Naples, US). The FDA issued a Cleared decision on June 12, 2001, 69 days after receiving the submission on April 4, 2001.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3040.
| 510(k) Number | K011007 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 04, 2001 |
| Decision Date | June 12, 2001 |
| Days to Decision | 69 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | MBI — Fastener, Fixation, Nondegradable, Soft Tissue |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3040 |