K042066 is an FDA 510(k) clearance for the KLSA MARTIN HAND DISTRACTOR. This device is classified as a Component, Traction, Invasive (Class II - Special Controls, product code JEC).
Submitted by KLS-Martin L.P. (Jacksonville, US). The FDA issued a Cleared decision on August 25, 2004, 23 days after receiving the submission on August 2, 2004.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3040.
| 510(k) Number | K042066 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 02, 2004 |
| Decision Date | August 25, 2004 |
| Days to Decision | 23 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | JEC — Component, Traction, Invasive |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3040 |