Synthes 4.5mm VA-LCP Curved Condylar Plate System Line Extension, Variable Angle Positioning Pins

Condylar Plate Fixation Implant

DePuy Synthes

The following data is part of a premarket notification filed by Depuy Synthes with the FDA for Synthes 4.5mm Va-lcp Curved Condylar Plate System Line Extension, Variable Angle Positioning Pins.

Pre-market Notification Details

• Device ID: K162124
• 510k Number: K162124
• Device Name: Synthes 4.5mm VA-LCP Curved Condylar Plate System Line Extension, Variable Angle Positioning Pins
• Classification: Condylar Plate Fixation Implant
• Applicant: DePuy Synthes 1301 GOSHEN PARKWAY West Chester, PA 19380
• Contact: Christopher J. Medberry
• Correspondent: Christopher J. Medberry; DePuy Synthes 1301 GOSHEN PARKWAY West Chester, PA 19380
• Product Code: JDP
• Subsequent Product Code: HRS
• Subsequent Product Code: HWC
• Subsequent Product Code: JDQ
• CFR Regulation Number: 888.3030 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-08-01
• Decision Date: 2017-03-29
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
H679422316900	K162124	000
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H679422316200	K162124	000
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H679422312200	K162124	000
H67942231008S0	K162124	000