AVA NAVIGATOR PEEK SPACERS, MODEL 48392XXX, 48393XXX

Intervertebral Fusion Device With Bone Graft, Lumbar

STRYKER SPINE

The following data is part of a premarket notification filed by Stryker Spine with the FDA for Ava Navigator Peek Spacers, Model 48392xxx, 48393xxx.

Pre-market Notification Details

Device IDK100865
510k NumberK100865
Device Name:AVA NAVIGATOR PEEK SPACERS, MODEL 48392XXX, 48393XXX
ClassificationIntervertebral Fusion Device With Bone Graft, Lumbar
Applicant STRYKER SPINE 2 PEARL COURT Allendale,  NJ  07401
ContactKimberly S Lane
CorrespondentKimberly S Lane
STRYKER SPINE 2 PEARL COURT Allendale,  NJ  07401
Product CodeMAX  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-03-29
Decision Date2010-08-11
Summary:summary

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