Stryker IVAS Elite Inflatable Vertebral Augmentation System (Stryker IVAS Elite Balloon Catheter)

Arthroscope

Stryker Corporation

The following data is part of a premarket notification filed by Stryker Corporation with the FDA for Stryker Ivas Elite Inflatable Vertebral Augmentation System (stryker Ivas Elite Balloon Catheter).

Pre-market Notification Details

Device IDK172116
510k NumberK172116
Device Name:Stryker IVAS Elite Inflatable Vertebral Augmentation System (Stryker IVAS Elite Balloon Catheter)
ClassificationArthroscope
Applicant Stryker Corporation 4100 E. Milham Avenue Kalamazoo,  MI  49001
ContactKristi Ashton
CorrespondentKristi Ashton
Stryker Corporation 4100 E. Milham Avenue Kalamazoo,  MI  49001
Product CodeHRX  
CFR Regulation Number888.1100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-07-13
Decision Date2018-01-25
Summary:summary

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