K090975 is an FDA 510(k) clearance for the DEROYAL NON-LOCKING BONE FIXATION SYSTEM. This device is classified as a Plate, Fixation, Bone (Class II - Special Controls, product code HRS).
Submitted by Deroyal Industries, Inc. (Powell, US). The FDA issued a Cleared decision on April 12, 2010, 371 days after receiving the submission on April 6, 2009.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3030.
| 510(k) Number | K090975 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 06, 2009 |
| Decision Date | April 12, 2010 |
| Days to Decision | 371 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Statement |
| Product Code | HRS — Plate, Fixation, Bone |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3030 |