DYNAMIC HIP SCREW

Appliance, Fixation, Nail/blade/plate Combination, Multiple Component

SYNTHES (USA)

The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Dynamic Hip Screw.

Pre-market Notification Details

Device IDK791619
510k NumberK791619
Device Name:DYNAMIC HIP SCREW
ClassificationAppliance, Fixation, Nail/blade/plate Combination, Multiple Component
Applicant SYNTHES (USA) 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeKTT  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1979-08-21
Decision Date1979-08-28

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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