ORTHOLOC® 3Di Ankle Fracture Plating System

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 Fracture Plating System.

Pre-market Notification Details

• Device ID: K163044
• 510k Number: K163044
• Device Name: ORTHOLOC® 3Di Ankle Fracture Plating System
• Classification: Plate, Fixation, Bone
• Applicant: WRIGHT MEDICAL TECHNOLOGY, INC. 1023 CHERRY RD Memphis, TN 38117
• Contact: Val Myles
• Correspondent: Val Myles; WRIGHT MEDICAL TECHNOLOGY, INC. 1023 CHERRY RD 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: 2016-10-31
• Decision Date: 2017-01-26
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00889797067669	K163044	000
00889797067652	K163044	000
00889797067249	K163044	000
00889797067232	K163044	000
00889797067225	K163044	000
00889797067218	K163044	000