CLAW II POLYAXIAL COMPRESSION SYSTEM AND ORTHOLOC 3DSI LOCKING SCREWS

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 Claw Ii Polyaxial Compression System And Ortholoc 3dsi Locking Screws.

Pre-market Notification Details

• Device ID: K113014
• 510k Number: K113014
• Device Name: CLAW II POLYAXIAL COMPRESSION SYSTEM AND ORTHOLOC 3DSI LOCKING SCREWS
• Classification: Plate, Fixation, Bone
• Applicant: WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002
• Contact: Peggy S Rivers
• Correspondent: Peggy S Rivers; 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: 2011-10-11
• Decision Date: 2012-01-31
• Summary: summary

NIH GUDID Devices

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