MODIFICATION TO SYNTHES USS

Orthosis, Spinal Pedicle Fixation

SYNTHES SPINE

The following data is part of a premarket notification filed by Synthes Spine with the FDA for Modification To Synthes Uss.

Pre-market Notification Details

Device IDK000450
510k NumberK000450
Device Name:MODIFICATION TO SYNTHES USS
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 CodeKWQ
Subsequent Product CodeMNH
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-02-11
Decision Date2000-03-10

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