ORTHOFIX ANKLE HINDFOOT NAILING SYSTEM

Rod, Fixation, Intramedullary And Accessories

ORTHOFIX SRL

The following data is part of a premarket notification filed by Orthofix Srl with the FDA for Orthofix Ankle Hindfoot Nailing System.

Pre-market Notification Details

• Device ID: K141571
• 510k Number: K141571
• Device Name: ORTHOFIX ANKLE HINDFOOT NAILING SYSTEM
• Classification: Rod, Fixation, Intramedullary And Accessories
• Applicant: ORTHOFIX SRL 3451 PLANO PARKWAY Lewisville, TX 75056
• Contact: Troy Brooks
• Correspondent: Troy Brooks; ORTHOFIX SRL 3451 PLANO PARKWAY Lewisville, TX 75056
• Product Code: HSB
• CFR Regulation Number: 888.3020 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2014-06-12
• Decision Date: 2014-11-12
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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