PLUS PIVOT LINK UNIVERSAL SYSTEM

Orthosis, Spinal Pedicle Fixation

SPINEVISION, INC.

The following data is part of a premarket notification filed by Spinevision, Inc. with the FDA for Plus Pivot Link Universal System.

Pre-market Notification Details

Device IDK033508
510k NumberK033508
Device Name:PLUS PIVOT LINK UNIVERSAL SYSTEM
ClassificationOrthosis, Spinal Pedicle Fixation
Applicant SPINEVISION, INC. 3003 SUMMIT BLVD. SUITE 1400 Atlanta,  GA  30319
ContactLynnette Whitaker
CorrespondentLynnette Whitaker
SPINEVISION, INC. 3003 SUMMIT BLVD. SUITE 1400 Atlanta,  GA  30319
Product CodeMNI  
Subsequent Product CodeKWP
Subsequent Product CodeKWQ
Subsequent Product CodeMNH
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-11-06
Decision Date2004-01-27
Summary:summary

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