FDA 510(k) Applications Submitted by Stryker GMbH
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K230512 |
02/24/2023 |
Gamma4 System |
Stryker GmbH |
| K222309 |
08/01/2022 |
Gamma4 System |
Stryker GMBH |
| K213328 |
10/05/2021 |
Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing System |
Stryker GmbH |
| K193366 |
12/04/2019 |
T2 ICF |
Stryker GmbH |
| K231262 |
05/01/2023 |
Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System, Pangea Humerus Plating System |
Stryker GmbH |
| K231257 |
05/01/2023 |
Pangea Utility Plating System, Pangea Platform |
Stryker GmbH |
| K220319 |
02/03/2022 |
Asnis III Cannulated Screw System, Asnis PRO Cannulated Screw System |
Stryker GmbH |
| K210582 |
02/26/2021 |
EasyClip« and EasyClip« Xpress |
Stryker GmbH |
| K222381 |
08/05/2022 |
PeriPROÖ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating System |
Stryker GmbH |
| K213199 |
09/29/2021 |
Asnis« III Cannulated Screw System and Asnis« PRO Cannulated Screw System |
Stryker GmbH |
| K223772 |
12/16/2022 |
PRO Plating System, Stryker Trauma Pelvic Set (Matta) |
Stryker GMbH |
| K160813 |
03/24/2016 |
EasyStep |
STRYKER GMBH |
| K151879 |
07/09/2015 |
VariAx 2 One-Third Tubular Plating System |
STRYKER GMBH |
| K162439 |
08/31/2016 |
AxSOS 3 Ti; Stryker Plating System |
STRYKER GMBH |
| K162841 |
10/11/2016 |
VariAx Distal Radius Plating System, VariAx 2 System |
Stryker GmbH |
| K200880 |
04/02/2020 |
T2 Tibial Nailing System, T2 Femoral Nail System, T2 Supracondylar Nail System, T2 Recon Nail System, T2 Greater Trochanter Nail (GTN),T2 Ankle Arthrodesis Nail,T2 Arthrodesis Nail System |
Stryker GmbH |
| K172148 |
07/17/2017 |
Anchorage Bone Plating System |
Stryker GmbH |
| K182968 |
10/26/2018 |
Hoffmann LRF System |
Stryker GmbH |
| K201715 |
06/23/2020 |
Smart Toe II, X Fuse |
Stryker GmbH |
| K192675 |
09/26/2019 |
VariAx Foot |
Stryker GmbH |
| K203819 |
12/29/2020 |
T2 Alpha Femur Retrograde Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Tibial Nailing System, T2 Femoral System, T2 Supracondylar Nail System |
Stryker GmbH |
| K210861 |
03/23/2021 |
ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA) |
Stryker GmbH |
| K221346 |
05/09/2022 |
Stryker VariAx 2 MIS Calcaneus |
Stryker GmbH |
| K202289 |
08/12/2020 |
ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA) |
Stryker GmbH |
| K211508 |
05/14/2021 |
Steinmann Pins and Kirschner Wires |
Stryker GmbH |
| K212581 |
08/16/2021 |
VariAx 2 Distal Radius System, VariAx 2 Distal Ulna System |
Stryker GmbH |
| K172350 |
08/03/2017 |
AxSOS 3 Ti |
Stryker GmbH |
| K151769 |
06/30/2015 |
Anchorage 2 CP System |
STRYKER GMBH |
| K173946 |
12/27/2017 |
ADAPT for Gamma3 |
Stryker GmbH |
| K200398 |
02/18/2020 |
AxSOS 3 AF System and AxSOS 3 Ti System |
Stryker GmbH |
| K180500 |
02/26/2018 |
VariAx 2 System |
Stryker GmbH |
| K170771 |
03/14/2017 |
VariAx 2 Foot System |
Stryker GmbH |
| K161753 |
06/24/2016 |
Hoffman LRF System |
STRYKER GMBH |
| K173135 |
09/29/2017 |
VariAx 2 System |
Stryker GmbH |
| K153377 |
11/23/2015 |
Hoffmann LRF (Limb Reconstruction Frame) System |
Stryker GmbH |
| K163656 |
12/23/2016 |
Hoffmann LRF System |
Stryker GmbH |
| K181091 |
04/24/2018 |
AxSOS 3 Ti |
Stryker GmbH |
| K161863 |
07/06/2016 |
ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty (RSA), ReUnion Total Shoulder Arthroplasty (TSA) |
Stryker GmbH |
| K153379 |
11/23/2015 |
AxSOS 3Ti |
Stryker GmbH |
| K191412 |
05/28/2019 |
VariAx 2 System, VariAx 2 Mini Fragment System |
Stryker GmbH |
| K183104 |
11/08/2018 |
Mini Cannulated Headed and Headless Screw Set |
Stryker GmbH |
| K203568 |
12/07/2020 |
Hoffmann LRF System |
Stryker GmbH |
| K170727 |
03/09/2017 |
VariAx 2 Compression Plating System |
Stryker GmbH |
| 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 |
| K183039 |
11/01/2018 |
ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA) |
Stryker GmbH |
| K202749 |
09/21/2020 |
ADAPT for Gamma3 |
Stryker GmbH |
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