PARAGON POSTERIOR SPINAL SYSTEM

Orthosis, Spondylolisthesis Spinal Fixation

SOFAMOR DANEK USA,INC.

The following data is part of a premarket notification filed by Sofamor Danek Usa,inc. with the FDA for Paragon Posterior Spinal System.

Pre-market Notification Details

Device IDK950955
510k NumberK950955
Device Name:PARAGON POSTERIOR SPINAL SYSTEM
ClassificationOrthosis, Spondylolisthesis Spinal Fixation
Applicant SOFAMOR DANEK USA,INC. 1800 PYRAMID PLACE Memphis,  TN  38132
ContactRichard W Treharne
CorrespondentRichard W Treharne
SOFAMOR DANEK USA,INC. 1800 PYRAMID PLACE Memphis,  TN  38132
Product CodeMNH  
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent For Some Indications (SN)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-03-02
Decision Date1995-08-25

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