AccuLIF TL And PL Cage

Intervertebral Fusion Device With Bone Graft, Lumbar

STRYKER CORPORATION

The following data is part of a premarket notification filed by Stryker Corporation with the FDA for Acculif Tl And Pl Cage.

Pre-market Notification Details

Device IDK160715
510k NumberK160715
Device Name:AccuLIF TL And PL Cage
ClassificationIntervertebral Fusion Device With Bone Graft, Lumbar
Applicant STRYKER CORPORATION 2 PEARL COURT Allendale,  NJ  07401
ContactAakash Jain
CorrespondentTina Mornak
STRYKER CORPORATION 2 PEARL COURT Allendale,  NJ  07401
Product CodeMAX  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-03-15
Decision Date2016-07-08
Summary:summary

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