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Stryker

FDA 510(k) & PMA Approved Devices — 64 products

Total Devices64
Categories24
Latest Approval2023-09-20
TypeNumberDevice NameCodeDate
510(k) K231854 1788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with AIM OWN 2023-09-20 View
510(k) K230416 Triathlon® Hinge Knee System; Triathlon® Revision Insert X3® KRO 2023-05-19 View
510(k) K230754 L12 LED Light Source with AIM OWN 2023-04-11 View
510(k) K230605 1788 4K Camera System with Advanced Imaging Modality GCJ 2023-03-31 View
510(k) K230216 1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000) GCJ 2023-02-23 View
510(k) K222130 1688 4K Camera System with Advanced Imaging Modality GCJ 2022-08-19 View
510(k) K220731 Insignia Hip Stem, Restoration Modular 115mm Conical Distal Stem MEH 2022-08-11 View
510(k) K221611 780 nm L11 LED Light Source with AIM OWN 2022-06-29 View
510(k) K221217 SPY Laparoscope GCJ 2022-06-17 View
510(k) K214046 780 nm 1688 4K Camera System, 780 nm L11 LED Light Source with AIM and Safelight Cable GCJ 2022-05-25 View
510(k) K220895 1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000), 1688 4K Pendulum Camera Head (1688310130) GCJ 2022-04-22 View
510(k) K212511 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) GCJ 2021-11-04 View
510(k) K211202 1688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, Precision S 4K Sinuscopes GWG 2021-08-06 View
510(k) K210088 1688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, AIM Laparoscopes GCJ 2021-04-13 View
510(k) K210584 SDC3 HD Information Management System with Wireless Device Control Capability GCJ 2021-03-18 View
510(k) K203055 Stryker PEEK Customized Cranial Implant Kit GWO 2021-02-09 View
510(k) K202659 Stryker Arthroscope HRX 2020-12-01 View
510(k) K202355 Stryker Omega PEEK Knotless Anchor System MBI 2020-11-13 View
510(k) K202592 Adavanced Imaging Modality System (1688 4K Camera System With Advanced Imaging Modality, L11 LED Light Source with Adavanced Imaging Modality) GCJ 2020-10-08 View
510(k) K201434 Connected OR Hub with Voice Control, Connected OR Hub with Device Control GCJ 2020-07-28 View
510(k) K193136 Stryker Customized Mandible Recon Plate Kit JEY 2020-03-26 View
510(k) K193143 Stryker Facial iD Plating System JEY 2020-03-26 View
510(k) K200310 1688 Pendulum 4K Camera Head with Integrated Coupler, 1688 4K Camera Control Unit with Advanced Imaging Modality GCJ 2020-03-06 View
510(k) K200117 Trevo NXT ProVue Retriever POL 2020-02-07 View
510(k) K192122 Trevo Trak 21 Microcatheter DQO 2019-11-22 View
510(k) K192207 Trevo NXT ProVue Retriever POL 2019-11-22 View
510(k) K192292 L10 LED Light Source with AIM, L11 LED Light Source with AIM, AIM SafeLight Cable OWN 2019-11-19 View
510(k) K192172 Connected OR Hub with Device and Voice Control GCJ 2019-09-09 View
510(k) K191102 Precision S 4K Sinuscope EOB 2019-09-06 View
510(k) K190229 Stryker PEEK Customized Cranial Implant Kit GWO 2019-07-11 View
510(k) K190696 Stryker Surgeon iD Mandible Recon Plate JEY 2019-06-28 View
510(k) K190779 Trevo XP ProVue Retriever POL 2019-06-25 View
510(k) K190172 Stryker Elite Attachments, Stryker Heavy Duty (HD) Attachments HBE 2019-06-14 View
510(k) K183381 Navigation Enabled Instruments OLO 2019-05-17 View
510(k) K191046 L10 LED Light Source with AIM, L11 LED Light Source with AIM OWN 2019-05-10 View
510(k) K190843 Synchro2 Support Guidewire MOF 2019-05-01 View
510(k) K183463 AXS Catalyst Distal Access Catheter 068 x 115cm, AXS Catalyst Distal Access Catheter 068 x 125cm, AXS Catalyst Distal Access Catheter 068 x 132cm DQY 2019-03-13 View
510(k) K183464 AXS Catalyst 7 Distal Access Catheter (068 x 115cm, 068 x 125cm, 068 x 132cm) NRY 2019-03-13 View
510(k) K183172 Stryker SternalPlate System HRS 2019-03-05 View
510(k) K182305 Stryker Facial iD Plating System JEY 2019-01-07 View
510(k) K183470 Precision Ideal Eyes Arthroscopes HRX 2019-01-07 View
510(k) K182160 1688 Camera Control Unit ; 1688 AIM 4K Camera Head, C-Mount ; 1688 AIM 4K Camera Head with Integrated Coupler ; AIM 4K Coupler, 20mm, C-Mount ; L11 LED Light Source with AIM GCJ 2018-11-05 View
510(k) K181258 ConnectedOR Hub with Device and Voice Control GCJ 2018-11-05 View
510(k) K181504 Stryker Pediatric Mandibular Distractor 2 MQN 2018-09-11 View
510(k) K181083 Stryker All-PEEK Knotless Anchor System MBI 2018-07-23 View
510(k) K173074 ICONIX XBraid TT with Needles, NanoTack TT Suture Anchor MBI 2018-04-04 View
510(k) K173841 AXS Catalyst Distal Access Catheter 058 x 115cm; AXS Catalyst Distal Access Catheter 058 x 132cm; AXS Catalyst Distal Access Catheter 060 x 132cm NRY 2018-03-18 View
510(k) K171391 Stryker 90-S Max SERFAS Energy Probe GEI 2018-01-26 View
510(k) K173866 Stryker AIM Light Source and SafeLight cable OWN 2018-01-18 View
510(k) K173476 Tritanium® TL Curved Posterior Lumbar Cage MAX 2018-01-18 View
510(k) K172921 Stryker Self-Punching ICONIX MBI 2017-11-20 View
510(k) K170725 Stryker Universal Mesh GWO 2017-11-13 View
510(k) K170773 Stryker Universal Mesh JEY 2017-11-08 View
510(k) K172572 Stryker Upper-Face AXS screws and Mid-Face AXS screws JEY 2017-10-31 View
510(k) K171465 Stryker Self-Punching ICONIX MBI 2017-08-24 View
510(k) K171364 MP LeFort I Plates JEY 2017-07-24 View
510(k) K171152 Stryker Universal Neuro III System AXS Screw HBW 2017-05-19 View
510(k) K170098 ICONIX TT All Suture Anchor MBI 2017-03-31 View
510(k) K161821 Stryker Universal Mesh GWO 2016-12-08 View
510(k) K162310 XBraid TT Suture Tape GAT 2016-11-10 View
510(k) K162262 Tritanium® PL Cage MAX 2016-11-09 View
510(k) K160955 Tritanium® PL Cage MAX 2016-07-21 View
510(k) K153248 PEEK Customized Cranial Implant GWO 2016-03-10 View
510(k) K153508 Stryker CMF MEDPOR Customized Implant FWP 2016-02-05 View
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