AERO -C Cervical Cage System

Intervertebral Fusion Device With Bone Graft, Cervical

STRYKER SPINE

The following data is part of a premarket notification filed by Stryker Spine with the FDA for Aero -c Cervical Cage System.

Pre-market Notification Details

Device IDK152532
510k NumberK152532
Device Name:AERO -C Cervical Cage System
ClassificationIntervertebral Fusion Device With Bone Graft, Cervical
Applicant STRYKER SPINE 2 PEARL COURT Allendale,  NJ  07401
ContactSoraya King
CorrespondentSoraya King
STRYKER SPINE 2 PEARL COURT Allendale,  NJ  07401
Product CodeODP  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-09-03
Decision Date2015-12-18
Summary:summary

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