VALOR(R) ANKLE FUSION NAIL SYSTEM SCREW

Rod, Fixation, Intramedullary And Accessories

WRIGHT MEDICAL TECHNOLOGY, INC.

The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for Valor(r) Ankle Fusion Nail System Screw.

Pre-market Notification Details

• Device ID: K110552
• 510k Number: K110552
• Device Name: VALOR(R) ANKLE FUSION NAIL SYSTEM SCREW
• Classification: Rod, Fixation, Intramedullary And Accessories
• Applicant: WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002
• Contact: Ryan Bormann
• Correspondent: Ryan Bormann; WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002
• Product Code: HSB
• CFR Regulation Number: 888.3020 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2011-02-28
• Decision Date: 2011-03-23
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00840420115997	K110552	000
00840420115980	K110552	000
00840420115973	K110552	000
00840420115966	K110552	000