UNI-T UNI-THREAD SPINAL SYSTEM

Orthosis, Spinal Pedicle Fixation

SPINE VISION, INC

The following data is part of a premarket notification filed by Spine Vision, Inc with the FDA for Uni-t Uni-thread Spinal System.

Pre-market Notification Details

Device IDK021510
510k NumberK021510
Device Name:UNI-T UNI-THREAD SPINAL SYSTEM
ClassificationOrthosis, Spinal Pedicle Fixation
Applicant SPINE VISION, INC 3003 SUMMIT BLVD. 15TH FLOOR SUITE 1500 Atlanta,  GA  30319
ContactLynnette Whitaker
CorrespondentLynnette Whitaker
SPINE VISION, INC 3003 SUMMIT BLVD. 15TH FLOOR SUITE 1500 Atlanta,  GA  30319
Product CodeMNI  
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-05-09
Decision Date2002-08-01
Summary:summary

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