Medical Device Manufacturer · US , Portage , MI

Stryker

92 submissions · 92 cleared · Since 2006
92
Total
92
Cleared
0
Denied

Stryker — FDA 510(k) Submissions

Stryker has submitted 92 FDA 510(k) premarket notifications since 2006, of which 92 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Laparoscope, General & Plastic Surgery, Plate, Bone, Plate, Cranioplasty, Preformed, Alterable, Fastener, Fixation, Nondegradable, Soft Tissue, Confocal Optical Imaging . Use the specialty filter in the sidebar to narrow results.

92 devices
1–25 of 92
1788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with AIM
K231854 · OWN Confocal Optical Imaging · General & Plastic Surgery
Sep 2023 89d
Triathlon? Hinge Knee System; Triathlon? Revision Insert X3?
K230416 · KRO Prosthesis, Knee,... · Orthopedic
May 2023 92d
L12 LED Light Source with AIM
K230754 · OWN Confocal Optical Imaging · General & Plastic Surgery
Apr 2023 25d
1788 4K Camera System with Advanced Imaging Modality
K230605 · GCJ Laparoscope, General &... · General & Plastic Surgery
Mar 2023 28d
1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000)
K230216 · GCJ Laparoscope, General &... · General & Plastic Surgery
Feb 2023 28d
1688 4K Camera System with Advanced Imaging Modality
K222130 · GCJ Laparoscope, General &... · General & Plastic Surgery
Aug 2022 32d
Insignia Hip Stem, Restoration Modular 115mm Conical Distal Stem
K220731 · MEH Prosthesis, Hip,... · Orthopedic
Aug 2022 150d
780 nm L11 LED Light Source with AIM
K221611 · OWN Confocal Optical Imaging · General & Plastic Surgery
Jun 2022 26d
SPY Laparoscope
K221217 · GCJ Laparoscope, General &... · General & Plastic Surgery
Jun 2022 51d
780 nm 1688 4K Camera System, 780 nm L11 LED Light Source with AIM and Safelight Cable
K214046 · GCJ Laparoscope, General &... · General & Plastic Surgery
May 2022 149d
1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000), 1688 4K Pendulum Camera Head (1688310130)
K220895 · GCJ Laparoscope, General &... · General & Plastic Surgery
Apr 2022 25d
1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000), AIM 4K Autoclave Camera Head, C-Mount (1688410105), AIM 4K Autoclave Coupler, C-Mount (1688410110)
K212511 · GCJ Laparoscope, General &... · General & Plastic Surgery
Nov 2021 86d
1688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, Precision S 4K Sinuscopes
K211202 · GWG Endoscope, Neurological · Neurology
Aug 2021 106d
1688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, AIM Laparoscopes
K210088 · GCJ Laparoscope, General &... · General & Plastic Surgery
Apr 2021 90d
SDC3 HD Information Management System with Wireless Device Control Capability
K210584 · GCJ Laparoscope, General &... · General & Plastic Surgery
Mar 2021 20d
Stryker PEEK Customized Cranial Implant Kit
K203055 · GWO Plate, Cranioplasty,... · Neurology
Feb 2021 124d
Stryker Arthroscope
K202659 · HRX Arthroscope · Orthopedic
Dec 2020 78d
Stryker Omega PEEK Knotless Anchor System
K202355 · MBI Fastener, Fixation,... · Orthopedic
Nov 2020 86d
Adavanced Imaging Modality System (1688 4K Camera System With Advanced Imaging Modality, L11 LED Light Source with Adavanced Imaging Modality)
K202592 · GCJ Laparoscope, General &... · General & Plastic Surgery
Oct 2020 30d
Connected OR Hub with Voice Control, Connected OR Hub with Device Control
K201434 · GCJ Laparoscope, General &... · General & Plastic Surgery
Jul 2020 57d
Stryker Customized Mandible Recon Plate Kit
K193136 · JEY Plate, Bone · Dental
Mar 2020 134d
Stryker Facial iD Plating System
K193143 · JEY Plate, Bone · Dental
Mar 2020 134d
1688 Pendulum 4K Camera Head with Integrated Coupler, 1688 4K Camera Control Unit with Advanced Imaging Modality
K200310 · GCJ Laparoscope, General &... · General & Plastic Surgery
Mar 2020 29d
Trevo NXT ProVue Retriever
K200117 · POL Neurovascular Mechanical... · Neurology
Feb 2020 17d
Trevo Trak 21 Microcatheter
K192122 · DQO Catheter, Intravascular,... · Neurology
Nov 2019 108d

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