RIVAL View Plating Systems And Reduce Fracture Plating Systems

Plate, Fixation, Bone

Orthofix Srl

The following data is part of a premarket notification filed by Orthofix Srl with the FDA for Rival View Plating Systems And Reduce Fracture Plating Systems.

Pre-market Notification Details

• Device ID: K190388
• 510k Number: K190388
• Device Name: RIVAL View Plating Systems And Reduce Fracture Plating Systems
• Classification: Plate, Fixation, Bone
• Applicant: Orthofix Srl Via Delle Nazioni, 9 Bussolengo, IT 37012
• Contact: Gianluca Ricadona
• Correspondent: Cheryl Wagoner; Wagoner Consulting LLC PO Box 15729 Wilmington, NC 24408
• Product Code: HRS
• CFR Regulation Number: 888.3030 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-02-19
• Decision Date: 2019-06-07

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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