Quantum Anterior Cervical Plate

Appliance, Fixation, Spinal Intervertebral Body

Nvision Biomedical Technologies, Inc.

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

Pre-market Notification Details

• Device ID: K210424
• 510k Number: K210424
• Device Name: Quantum Anterior Cervical Plate
• Classification: Appliance, Fixation, Spinal Intervertebral Body
• Applicant: Nvision Biomedical Technologies, Inc. 4590 Lockhill Selma San Antonio, TX 78249
• Contact: Diana Langham
• Correspondent: Analaura Villarreal-berain; Nvision Biomedical Technologies, Inc. 4590 Lockhill Selma San Antonio, TX 78249
• Product Code: KWQ
• CFR Regulation Number: 888.3060 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2021-02-11
• Decision Date: 2021-10-22

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
90810005669170	K210424	000
90810005669125	K210424	000
90810005669064	K210424	000
90810005669057	K210424	000