Submission Details
| 510(k) Number | K210408 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 11, 2021 |
| Decision Date | April 08, 2021 |
| Days to Decision | 56 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
Cleared
Traditional
DePuy Synthes Variable Angle Locking Patella Plating System
Apr 2021
Decision
56d
Days
Class 2
Risk
About This 510(k) Submission
K210408 is an FDA 510(k) clearance for the DePuy Synthes Variable Angle Locking Patella Plating System, a Plate, Fixation, Bone (Class II — Special Controls, product code HRS), submitted by Synthes USA Products, LLC (19380, US). The FDA issued a Cleared decision on April 8, 2021, 56 days after receiving the submission on February 11, 2021. 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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