K090374 is an FDA 510(k) clearance for the STERILE DVR ANATOMIC PLATES VARIOUS CONFIGURATIONS) MODEL (S) 131212001,2, 5-10 2.5MM THREADED AND SMOOTH PEGS, MODEL(S. This device is classified as a Appliance, Fixation, Nail/blade/plate Combination, Multiple Component, Metal Composite (Class II - Special Controls, product code LXT).
Submitted by DePuy Orthopaedics, Inc. (Warsaw, US). The FDA issued a Cleared decision on March 11, 2009, 22 days after receiving the submission on February 17, 2009.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3030.
| 510(k) Number | K090374 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 17, 2009 |
| Decision Date | March 11, 2009 |
| Days to Decision | 22 days |
| Submission Type | Special |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | LXT - Appliance, Fixation, Nail/blade/plate Combination, Multiple Component, Metal Composite |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3030 |