AVS ANTERIOR LARGE PEEK SPACERS

Intervertebral Fusion Device With Bone Graft, Lumbar

STRYKER CORP.

The following data is part of a premarket notification filed by Stryker Corp. with the FDA for Avs Anterior Large Peek Spacers.

Pre-market Notification Details

Device IDK090166
510k NumberK090166
Device Name:AVS ANTERIOR LARGE PEEK SPACERS
ClassificationIntervertebral Fusion Device With Bone Graft, Lumbar
Applicant STRYKER CORP. 2 PEARL COURT Allendale,  NJ  07401
ContactVikki M O'connor
CorrespondentVikki M O'connor
STRYKER CORP. 2 PEARL COURT Allendale,  NJ  07401
Product CodeMAX  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-01-22
Decision Date2009-04-22
Summary:summary

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