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 IDK141217
510k NumberK141217
Device Name:ACCULIF TL AND PL CAGE
ClassificationIntervertebral Fusion Device With Bone Graft, Lumbar
Applicant STRYKER CORPORATION 2 PEARL COURT Allendale,  NJ  07401
ContactKristen Meany
CorrespondentKristen Meany
STRYKER CORPORATION 2 PEARL COURT Allendale,  NJ  07401
Product CodeMAX  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-05-12
Decision Date2014-07-16
Summary:summary

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