ORTHOLOC 3DI HALLUX 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 Hallux System.

Pre-market Notification Details

• Device ID: K120359
• 510k Number: K120359
• Device Name: ORTHOLOC 3DI HALLUX SYSTEM
• Classification: Plate, Fixation, Bone
• Applicant: WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002
• Contact: Leslie Fitch
• Correspondent: Leslie Fitch; WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002
• Product Code: HRS
• CFR Regulation Number: 888.3030 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2012-02-06
• Decision Date: 2012-05-03
• Summary: summary

NIH GUDID Devices

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