ORTHOLOC® 3Di Ankle Fusion Plating System Line Extension

Plate, Fixation, Bone

Wright Medical Technology, Inc.

The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for Ortholoc® 3di Ankle Fusion Plating System Line Extension.

Pre-market Notification Details

• Device ID: K163650
• 510k Number: K163650
• Device Name: ORTHOLOC® 3Di Ankle Fusion Plating System Line Extension
• Classification: Plate, Fixation, Bone
• Applicant: Wright Medical Technology, Inc. 1023 Cherry Road Memphis, TN 38117
• Contact: Rachel Roberts
• Correspondent: Rachel Roberts; Wright Medical Technology, Inc. 1023 Cherry Road Memphis, TN 38117
• Product Code: HRS
• CFR Regulation Number: 888.3030 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-12-23
• Decision Date: 2017-04-24
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00840420193582	K163650	000