Nva, Nvp, Nvt

Intervertebral Fusion Device With Bone Graft, Lumbar

NVISION BIOMEDICAL TECHNOLOGIES, LLC

The following data is part of a premarket notification filed by Nvision Biomedical Technologies, Llc with the FDA for Nva, Nvp, Nvt.

Pre-market Notification Details

• Device ID: K142594
• 510k Number: K142594
• Device Name: Nva, Nvp, Nvt
• Classification: Intervertebral Fusion Device With Bone Graft, Lumbar
• Applicant: NVISION BIOMEDICAL TECHNOLOGIES, LLC 18618 TUSCANY STONE SUITE 120 San Antonio, TN 78258
• Contact: Brian Kieser
• Correspondent: Jennifer Palinchik; JALEX MEDICAL, LLC 27881 CLEMENS ROAD SUITE 2 Westlake, OH 44145
• Product Code: MAX
• CFR Regulation Number: 888.3080 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2014-09-15
• Decision Date: 2014-11-28
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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