SYNTHES (U.S.A.) UNIVERSAL SACRAL SYSTEM

Orthosis, Spondylolisthesis Spinal Fixation

SYNTHES (USA)

The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes (u.s.a.) Universal Sacral System.

Pre-market Notification Details

Device IDK963045
510k NumberK963045
Device Name:SYNTHES (U.S.A.) UNIVERSAL SACRAL SYSTEM
ClassificationOrthosis, Spondylolisthesis Spinal Fixation
Applicant SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli,  PA  19301 -1222
ContactDiane T Brown
CorrespondentDiane T Brown
SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli,  PA  19301 -1222
Product CodeMNH  
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-08-05
Decision Date1997-02-13
Summary:summary

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