C3 ANTERIOR CERVICAL PLATE SYSTEM

Appliance, Fixation, Spinal Intervertebral Body

SPINE VISION, INC

The following data is part of a premarket notification filed by Spine Vision, Inc with the FDA for C3 Anterior Cervical Plate System.

Pre-market Notification Details

Device IDK012881
510k NumberK012881
Device Name:C3 ANTERIOR CERVICAL PLATE SYSTEM
ClassificationAppliance, Fixation, Spinal Intervertebral Body
Applicant SPINE VISION, INC BOX 39 367 PLEASANT VALLEY RD. Good Hope,  GA  30641
ContactDavid W Mullis, Jr
CorrespondentDavid W Mullis, Jr
SPINE VISION, INC BOX 39 367 PLEASANT VALLEY RD. Good Hope,  GA  30641
Product CodeKWQ  
CFR Regulation Number888.3060 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-08-28
Decision Date2001-11-26
Summary:summary

NIH GUDID Devices

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