S4 Cervical Spinal And Occiput Systems

Posterior Cervical Screw System

AESCULAP IMPLANT SYSTEMS, LLC

The following data is part of a premarket notification filed by Aesculap Implant Systems, Llc with the FDA for S4 Cervical Spinal And Occiput Systems.

Pre-market Notification Details

Device IDK151938
510k NumberK151938
Device Name:S4 Cervical Spinal And Occiput Systems
ClassificationPosterior Cervical Screw System
Applicant AESCULAP IMPLANT SYSTEMS, LLC 3773 Corporate Parkway Center Valley,  PA  18034
ContactLisa Boyle
CorrespondentLisa M. Boyle
AESCULAP IMPLANT SYSTEMS, LLC 3773 Corporate Parkway Center Valley,  PA  18034
Product CodeNKG  
CFR Regulation Number888.3075 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-07-14
Decision Date2015-10-21
Summary:summary

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