ORTHOLOC ANKLE PLATING SYSTEM (APS)

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 Ankle Plating System (aps).

Pre-market Notification Details

• Device ID: K091243
• 510k Number: K091243
• Device Name: ORTHOLOC ANKLE PLATING SYSTEM (APS)
• Classification: Plate, Fixation, Bone
• Applicant: WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002
• Contact: Sarah Holtgrewe
• Correspondent: Sarah Holtgrewe; 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: 2009-04-28
• Decision Date: 2009-06-26
• Summary: summary

NIH GUDID Devices

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