DePuy Synthes 3.5/4.5 Mm Variable Angle LCP Periprosthetic Proximal Femur Plating System

Plate, Fixation, Bone

Synthes (USA) Products, LLC

The following data is part of a premarket notification filed by Synthes (usa) Products, Llc with the FDA for Depuy Synthes 3.5/4.5 Mm Variable Angle Lcp Periprosthetic Proximal Femur Plating System.

Pre-market Notification Details

• Device ID: K210205
• 510k Number: K210205
• Device Name: DePuy Synthes 3.5/4.5 Mm Variable Angle LCP Periprosthetic Proximal Femur Plating System
• Classification: Plate, Fixation, Bone
• Applicant: Synthes (USA) Products, LLC 1301 Goshen Parkway West Chester, PA 19380
• Contact: Satapa Dhamankar
• Correspondent: Satapa Dhamankar; Synthes (USA) Products, LLC 1301 Goshen Parkway West Chester, PA 19380
• Product Code: HRS
• CFR Regulation Number: 888.3030 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2021-01-26
• Decision Date: 2021-03-26

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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