SYNTHES 90 DEGREE SCREWDRIVER

Drill, Bone, Powered

SYNTHES (USA)

The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes 90 Degree Screwdriver.

Pre-market Notification Details

Device IDK082649
510k NumberK082649
Device Name:SYNTHES 90 DEGREE SCREWDRIVER
ClassificationDrill, Bone, Powered
Applicant SYNTHES (USA) 1301 GOSHEN PKWY. West Chester,  PA  19380
ContactAndrea M Tasker
CorrespondentAndrea M Tasker
SYNTHES (USA) 1301 GOSHEN PKWY. West Chester,  PA  19380
Product CodeDZI  
CFR Regulation Number872.4120 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-09-12
Decision Date2009-04-30
Summary:summary

NIH GUDID Devices

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