PCT System

Posterior Cervical Screw System

CENTINEL SPINE, INC.

The following data is part of a premarket notification filed by Centinel Spine, Inc. with the FDA for Pct System.

Pre-market Notification Details

Device IDK152211
510k NumberK152211
Device Name:PCT System
ClassificationPosterior Cervical Screw System
Applicant CENTINEL SPINE, INC. 900 AIRPORT ROAD, SUITE 3B West Chester,  PA  19380
ContactJessica Staub
CorrespondentJessica Staub
CENTINEL SPINE, INC. 900 Airport Road, Suite 3B West Chester,  PA  19380
Product CodeNKG  
CFR Regulation Number888.3075 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-08-07
Decision Date2015-12-01
Summary:summary

NIH GUDID Devices

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