SYNTHES PEDIATRIC ROD 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 Pediatric Rod System.

Pre-market Notification Details

Device IDK991552
510k NumberK991552
Device Name:SYNTHES PEDIATRIC ROD SYSTEM
ClassificationOrthosis, Spondylolisthesis Spinal Fixation
Applicant SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli,  PA  19301 -1222
ContactJonathan Gilbert
CorrespondentJonathan Gilbert
SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli,  PA  19301 -1222
Product CodeMNH  
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-05-03
Decision Date1999-06-02
Summary:summary

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