ACP 1 Anterior Cervical Plating System

Appliance, Fixation, Spinal Intervertebral Body

STRYKER CORPORATION

The following data is part of a premarket notification filed by Stryker Corporation with the FDA for Acp 1 Anterior Cervical Plating System.

Pre-market Notification Details

Device IDK150700
510k NumberK150700
Device Name:ACP 1 Anterior Cervical Plating System
ClassificationAppliance, Fixation, Spinal Intervertebral Body
Applicant STRYKER CORPORATION 2 PEARL COURT Allendale,  NJ  07401
ContactTina Mornak
CorrespondentTina Mornak
STRYKER CORPORATION 2 PEARL COURT Allendale,  NJ  07401
Product CodeKWQ  
CFR Regulation Number888.3060 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-03-18
Decision Date2015-07-15
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07613327122176 K150700 000
07613327122367 K150700 000
07613327122374 K150700 000
07613327122381 K150700 000
07613327122398 K150700 000
07613327122404 K150700 000
07613327122411 K150700 000
07613327122428 K150700 000
07613327122435 K150700 000
07613327122442 K150700 000
07613327122459 K150700 000
07613327122466 K150700 000
07613327122473 K150700 000
07613327122480 K150700 000
07613327122497 K150700 000
07613327122503 K150700 000
07613327122350 K150700 000
07613327122343 K150700 000
07613327122336 K150700 000
07613327122183 K150700 000
07613327122190 K150700 000
07613327122206 K150700 000
07613327122213 K150700 000
07613327122220 K150700 000
07613327122237 K150700 000
07613327122244 K150700 000
07613327122251 K150700 000
07613327122268 K150700 000
07613327122275 K150700 000
07613327122282 K150700 000
07613327122299 K150700 000
07613327122305 K150700 000
07613327122312 K150700 000
07613327122329 K150700 000
07613327122510 K150700 000
07613327122527 K150700 000
07613327122718 K150700 000
07613327122725 K150700 000
07613327122732 K150700 000
07613327122749 K150700 000
07613327122756 K150700 000
07613327122763 K150700 000
07613327122770 K150700 000
07613327122787 K150700 000
07613327122794 K150700 000
07613327122800 K150700 000
07613327122817 K150700 000
07613327122824 K150700 000
07613327122831 K150700 000
07613327122848 K150700 000
07613327122855 K150700 000
07613327122701 K150700 000
07613327122695 K150700 000
07613327122688 K150700 000
07613327122534 K150700 000
07613327122541 K150700 000
07613327122558 K150700 000
07613327122565 K150700 000
07613327122572 K150700 000
07613327122589 K150700 000
07613327122596 K150700 000
07613327122602 K150700 000
07613327122619 K150700 000
07613327122626 K150700 000
07613327122633 K150700 000
07613327122640 K150700 000
07613327122657 K150700 000
07613327122664 K150700 000
07613327122671 K150700 000
07613327122862 K150700 000

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