SYNTHES SPINE POSTERIOR UNIVERSAL SYSTEM

Orthosis, Spinal Pedicle Fixation

SYNTHES SPINE

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

Pre-market Notification Details

Device IDK984612
510k NumberK984612
Device Name:SYNTHES SPINE POSTERIOR UNIVERSAL SYSTEM
ClassificationOrthosis, Spinal Pedicle Fixation
Applicant SYNTHES SPINE P.O. BOX 0548 1690 RUSSELL ROAD Paoli,  PA  19301
ContactJonathan Gilbert
CorrespondentJonathan Gilbert
SYNTHES SPINE P.O. BOX 0548 1690 RUSSELL ROAD Paoli,  PA  19301
Product CodeMNI  
Subsequent Product CodeKWP
Subsequent Product CodeMNH
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-12-24
Decision Date1999-01-19
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.