AVAmax Vertebral Balloon, AVAflex Vertebral Balloon

Arthroscope

STRYKER CORPORATION

The following data is part of a premarket notification filed by Stryker Corporation with the FDA for Avamax Vertebral Balloon, Avaflex Vertebral Balloon.

Pre-market Notification Details

Device IDK162062
510k NumberK162062
Device Name:AVAmax Vertebral Balloon, AVAflex Vertebral Balloon
ClassificationArthroscope
Applicant STRYKER CORPORATION 4100 E MILHAM AVE Kalamazoo,  MI  49001
ContactBecky Ditty
CorrespondentBecky Ditty
STRYKER CORPORATION 4100 E MILHAM AVE Kalamazoo,  MI  49001
Product CodeHRX  
CFR Regulation Number888.1100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-07-26
Decision Date2016-11-01
Summary:summary

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