Depuy Synthes Variable Angle Locking Hand System (1.3 Mm And 2.0 Mm Plates And Screws)

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 Variable Angle Locking Hand System (1.3 Mm And 2.0 Mm Plates And Screws).

Pre-market Notification Details

• Device ID: K150099
• 510k Number: K150099
• Device Name: Depuy Synthes Variable Angle Locking Hand System (1.3 Mm And 2.0 Mm Plates And Screws)
• Classification: Plate, Fixation, Bone
• Applicant: SYNTHES (USA) PRODUCTS, LLC 1301 GOSHEN PKWY. West Chester, PA 19380
• Contact: Nicholas Fountoulakis
• Correspondent: Nicholas Fountoulakis; SYNTHES (USA) PRODUCTS, LLC 1301 GOSHEN PKWY. 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: 2015-01-20
• Decision Date: 2015-03-23
• Summary: summary

NIH GUDID Devices

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