FDA 510(k) Applications Submitted by Tina Mornak

FDA 510(k) Number Submission Date Device Name Applicant
K230239 01/30/2023 AirSeal iFS System; AirSeal dV Solution CONMED Corporation
K170727 03/09/2017 VariAx 2 Compression Plating System Stryker GmbH
K150700 03/18/2015 ACP 1 Anterior Cervical Plating System STRYKER CORPORATION
K161407 05/20/2016 Ascential IBD PEEKc Spacer Stryker Spine
K161447 05/25/2016 HydroSet XT ORTHOVITA, INC.
K181742 07/02/2018 ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA) Stryker GmbH
K181848 07/11/2018 ADAPT for Gamma3, Gamma3 Stryker GMBH
K172210 07/24/2017 ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA) Stryker Trauma AG
K202303 08/14/2020 CORE E3 Suction/irrigator ConMed Corporation
K122637 08/29/2012 LITE DECOMPRESSION SYSTEM- LIGHT CABLE MODEL 48089999 STRYKER SPINE
K183039 11/01/2018 ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA) Stryker GmbH


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