MODIFICATION TO SYNTHES UNIVERSAL SPINAL SYSTEM

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 Universal Spinal System.

Pre-market Notification Details

Device IDK990745
510k NumberK990745
Device Name:MODIFICATION TO SYNTHES UNIVERSAL SPINAL SYSTEM
ClassificationOrthosis, Spinal Pedicle Fixation
Applicant SYNTHES SPINE P.O. BOX 0548 1690 RUSSELL ROAD Paoli,  PA  19301
ContactJ0nathan Gilbert
CorrespondentJ0nathan 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 Received1999-03-08
Decision Date1999-03-30
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
H9814982050 K990745 000
H9814982040 K990745 000
H9814982030 K990745 000

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