VAN HIP FRACTURE SYSTEM

Rod, Fixation, Intramedullary And Accessories

EPIX ORTHOPAEDIC, CORP.

The following data is part of a premarket notification filed by Epix Orthopaedic, Corp. with the FDA for Van Hip Fracture System.

Pre-market Notification Details

• Device ID: K133104
• 510k Number: K133104
• Device Name: VAN HIP FRACTURE SYSTEM
• Classification: Rod, Fixation, Intramedullary And Accessories
• Applicant: EPIX ORTHOPAEDIC, CORP. 1331 H STREET, NW, 12TH FLOOR Washington, DC 20008
• Contact: Michelle Mcdonough
• Correspondent: Michelle Mcdonough; EPIX ORTHOPAEDIC, CORP. 1331 H STREET, NW, 12TH FLOOR Washington, DC 20008
• Product Code: HSB
• CFR Regulation Number: 888.3020 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2013-09-30
• Decision Date: 2014-03-10
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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B2219001120051	K133104	000