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U.S. Department of Health and Human Services

510(k) Premarket Notification
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1 to 10 of 10 Results
ProductCode: NDN Applicant: STRYKER CORPORATION Decision Date To: 04/02/2023
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spinejack expansion kit Stryker Corporation K202393 10/20/2020
vertaplex hv high viscosity radiopaque bone cement; es2 augmentable spinal system Stryker Corporation K192818 03/31/2020
stryker ivas elite inflatable vertebral augmentation system (stryker ivas elite balloon catheter) Stryker Corporation K181752 12/21/2018
stryker ivas elite inflatable vertebral augmentation system (stryker ivas elite balloon catheter) Stryker Corporation K172116 01/25/2018
avamax vertebral balloon, avaflex vertebral balloon STRYKER CORPORATION K162062 11/01/2016
vertaplex® high viscosity (hv) radiopaque bone cement STRYKER CORPORATION K150582 06/12/2015
ivas 10mm and 15mm balloon catheter STRYKER CORPORATION K130430 05/23/2013
stryker ivas balloon catheter STRYKER CORPORATION K123942 04/03/2013
ivas balloon catheter STRYKER CORPORATION K113154 01/24/2012
ivas 2-10mm (10 guage) ballon catheter STRYKER CORPORATION K103807 06/28/2011
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