SYNTHES (USA) MODULAR BLADE PLATE SYSTEM

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

SYNTHES (USA)

The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes (usa) Modular Blade Plate System.

Pre-market Notification Details

Device IDK080109
510k NumberK080109
Device Name:SYNTHES (USA) MODULAR BLADE PLATE SYSTEM
ClassificationAppliance, Fixation, Nail/blade/plate Combination, Single Component
Applicant SYNTHES (USA) 1301 GOSHEN PKWY West Chester,  PA  19380
ContactJill R Sherman
CorrespondentJill R Sherman
SYNTHES (USA) 1301 GOSHEN PKWY West Chester,  PA  19380
Product CodeKTW  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-01-15
Decision Date2008-03-20
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.