Omnia Medical VBR

Spinal Vertebral Body Replacement Device

Omnia Medical, LLC

The following data is part of a premarket notification filed by Omnia Medical, Llc with the FDA for Omnia Medical Vbr.

Pre-market Notification Details

• Device ID: K172323
• 510k Number: K172323
• Device Name: Omnia Medical VBR
• Classification: Spinal Vertebral Body Replacement Device
• Applicant: Omnia Medical, LLC 1000 Hampton Center Suite G Morgantown, WV 26505
• Contact: Troy Schifano
• Correspondent: Kevin Majka; JALEX Medical 30311 Clemens Road Suite 5D Westlake, OH 44145
• Product Code: MQP
• CFR Regulation Number: 888.3060 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-08-01
• Decision Date: 2017-10-26
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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