ORTHOLOC® 3Di Foot Plating Reconstruction 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 Foot Plating Reconstruction System.

Pre-market Notification Details

• Device ID: K152974
• 510k Number: K152974
• Device Name: ORTHOLOC® 3Di Foot Plating Reconstruction System
• Classification: Plate, Fixation, Bone
• Applicant: Wright Medical Technology, Inc. 1023 Cherry Road Memphis, TN 38117
• Contact: Val Myles
• Correspondent: Val Myles; 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: 2015-10-08
• Decision Date: 2015-12-11
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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