K072212 is an FDA 510(k) clearance for the JET-X BAR SYSTEM CLAMPS, BARS AND POSTS-MR SAFE. This device is classified as a Appliance, Fixation, Nail/blade/plate Combination, Multiple Component (Class II - Special Controls, product code KTT).
Submitted by Smith & Nephew, Inc. (Memphis, US). The FDA issued a Cleared decision on March 7, 2008, 211 days after receiving the submission on August 9, 2007.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3030.
| 510(k) Number | K072212 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 09, 2007 |
| Decision Date | March 07, 2008 |
| Days to Decision | 211 days |
| Submission Type | Special |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | KTT — Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3030 |