Tangis Anterior Cervical Plate

Appliance, Fixation, Spinal Intervertebral Body

NVISION BIOMEDICAL TECHNOLOGIES, LLC

The following data is part of a premarket notification filed by Nvision Biomedical Technologies, Llc with the FDA for Tangis Anterior Cervical Plate.

Pre-market Notification Details

• Device ID: K161524
• 510k Number: K161524
• Device Name: Tangis Anterior Cervical Plate
• Classification: Appliance, Fixation, Spinal Intervertebral Body
• Applicant: NVISION BIOMEDICAL TECHNOLOGIES, LLC 1350 N LOOP 1604 E, SUITE 103 San Antonio, TX 78232
• Contact: Diana L. Langham
• Correspondent: Allison Komiyama; ACKNOWLEDGE REGULATORY STRATEGIES 2834 HAWTHORN ST. San Diego, CA 92104
• Product Code: KWQ
• CFR Regulation Number: 888.3060 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-06-02
• Decision Date: 2016-09-02
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
90814008020600	K161524	000
90814008023380	K161524	000
90814008023397	K161524	000
90814008023403	K161524	000
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90814008023847	K161524	000