DEPUY SYNTHES SPINE DENS ACCESS SYSTEM

Screw, Fixation, Bone

SYNTHES USA PRODUCTS, LLC

The following data is part of a premarket notification filed by Synthes Usa Products, Llc with the FDA for Depuy Synthes Spine Dens Access System.

Pre-market Notification Details

Device IDK132910
510k NumberK132910
Device Name:DEPUY SYNTHES SPINE DENS ACCESS SYSTEM
ClassificationScrew, Fixation, Bone
Applicant SYNTHES USA PRODUCTS, LLC 1302 WRIGHTS LANE EAST West Chester,  PA  19380
ContactEugene Bang
CorrespondentEugene Bang
SYNTHES USA PRODUCTS, LLC 1302 WRIGHTS LANE EAST West Chester,  PA  19380
Product CodeHWC  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-09-17
Decision Date2013-12-16
Summary:summary

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