Submission Details
| 510(k) Number | K092317 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 04, 2009 |
| Decision Date | November 02, 2009 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
Cleared
Traditional
DEROYAL NON-STERILE LOCKING COMPRESSION PLATE SYSTEM
Nov 2009
Decision
90d
Days
Class 2
Risk
About This 510(k) Submission
K092317 is an FDA 510(k) clearance for the DEROYAL NON-STERILE LOCKING COMPRESSION PLATE 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 November 2, 2009, 90 days after receiving the submission on August 4, 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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