FDA 510(k) Applications Submitted by Kristi Ashton

FDA 510(k) Number Submission Date Device Name Applicant
K180327 02/06/2018 Stryker iVAS 13g Bone Biopsy Kit Stryker Corporation
K150582 03/09/2015 Vertaplex« High Viscosity (HV) Radiopaque Bone Cement STRYKER CORPORATION
K181752 07/02/2018 Stryker iVAS Elite Inflatable Vertebral Augmentation System (Stryker iVAS Elite Balloon Catheter) Stryker Corporation
K172116 07/13/2017 Stryker iVAS Elite Inflatable Vertebral Augmentation System (Stryker iVAS Elite Balloon Catheter) Stryker Corporation
K202393 08/21/2020 SpineJack Expansion Kit Stryker Corporation
K172558 08/24/2017 iVAS 8g Bone Biopsy Kit, iVAS 11g Bone Biopsy Kit, iVAS 10g Bone Biopsy Kit Stryker Corporation
K192818 10/01/2019 Vertaplex HV High Viscosity Radiopaque Bone Cement; ES2 Augmentable Spinal System Stryker Corporation


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact