Synthes 4.5mm VA-LCP Curved Condylar Plate System Line Extension, Variable Angle Positioning Pins— 510(k) K162124
Substantially EquivalentDePuy Synthes
FDA 510(k) clearance K162124 for Synthes 4.5mm VA-LCP Curved Condylar Plate System Line Extension, Variable Angle Positioning Pins, Substantially Equivalent on 2017-03-29. Applicant: DePuy Synthes. Device class: 2.
Clearance details
- Applicant
- DePuy Synthes
- Product code
- Code JDP
- Device class
- Class 2
- Regulation
- 21 CFR 888.3030
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- West Chester, PA, US
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Adverse events under product code JDP
product code JDP- Injury
- 206
- Total
- 206
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.