Submission Details
| 510(k) Number | K090975 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
DEROYAL NON-LOCKING BONE FIXATION SYSTEM
Apr 2010
Decision
371d
Days
Class 2
Risk
About This 510(k) Submission
K090975 is an FDA 510(k) clearance for the DEROYAL NON-LOCKING BONE FIXATION SYSTEM, a Plate, Fixation, Bone (Class II — Special Controls, product code HRS), submitted by Deroyal Industries, Inc. (Knoxville, 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 review panel. Regulated under 21 CFR 888.3030.
Device Classification
| Product Code | HRS — Plate, Fixation, Bone |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 888.3030 |
Manufacturer
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