SYNTHES SPINE PEDIATRIC ROD SYSTEM

Orthosis, Spondylolisthesis Spinal Fixation

SYNTHES SPINE

The following data is part of a premarket notification filed by Synthes Spine with the FDA for Synthes Spine Pediatric Rod System.

Pre-market Notification Details

Device IDK980761
510k NumberK980761
Device Name:SYNTHES SPINE PEDIATRIC ROD SYSTEM
ClassificationOrthosis, Spondylolisthesis Spinal Fixation
Applicant SYNTHES SPINE P.O. BOX 0548 1690 RUSSELL ROAD Paoli,  PA  19301
ContactBarry E Sands
CorrespondentBarry E Sands
SYNTHES SPINE P.O. BOX 0548 1690 RUSSELL ROAD Paoli,  PA  19301
Product CodeMNH  
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-02-27
Decision Date1998-08-04
Summary:summary

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