SYNTHES USS (10.0MM SIDE OPENING SCREWS)

Appliance, Fixation, Spinal Intervertebral Body

SYNTHES

The following data is part of a premarket notification filed by Synthes with the FDA for Synthes Uss (10.0mm Side Opening Screws).

Pre-market Notification Details

Device IDK003061
510k NumberK003061
Device Name:SYNTHES USS (10.0MM SIDE OPENING SCREWS)
ClassificationAppliance, Fixation, Spinal Intervertebral Body
Applicant SYNTHES 1690 RUSSELL RD. P.O. BOX 1766 Paoli,  PA  19301
ContactJonathan Gilbert
CorrespondentJonathan Gilbert
SYNTHES 1690 RUSSELL RD. P.O. BOX 1766 Paoli,  PA  19301
Product CodeKWQ  
Subsequent Product CodeKWP
Subsequent Product CodeMNH
Subsequent Product CodeMNI
CFR Regulation Number888.3060 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-10-02
Decision Date2000-10-30

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10705034821306 K003061 000
10705034821160 K003061 000
10705034821177 K003061 000
10705034821184 K003061 000
10705034821191 K003061 000
10705034821207 K003061 000
10705034821221 K003061 000
10705034821245 K003061 000
10705034821269 K003061 000
10705034821283 K003061 000
10705034821153 K003061 000

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