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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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