Medical Device Manufacturer · US , Kalamazoo , MI

Stryker Instruments

71 submissions · 71 cleared · Since 1994
71
Total
71
Cleared
0
Denied

Stryker Instruments — FDA 510(k) Submissions

Stryker Instruments has submitted 71 FDA 510(k) premarket notifications since 1994, of which 71 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Electrosurgical, Cutting & Coagulation & Accessories, Neurological Stereotaxic Instrument, Gown, Surgical, Plate, Bone, Pump, Infusion . Use the specialty filter in the sidebar to narrow results.

71 devices
1–25 of 71
RPS Primary TKA Software; RPS Console; RPS Saw One; RPS Cable; RPS Saw Oscillating Tip Cartridge; RPS Console Cart Attachment; Ball Tip Pointer
K251971 · OLO Orthopedic Stereotaxic... · Orthopedic
Sep 2025 91d
PhotonBlade 3; PhotonBlade 3 Smoke Evacuation
K250483 · GEI Electrosurgical, Cutting... · Cardiovascular
Sep 2025 202d
OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Single Kit); OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Dual Kit)
K250213 · GXI Probe, Radiofrequency Lesion · Neurology
May 2025 111d
OptaBlate Radiofrequency (RF) Generator System
K250327 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Apr 2025 69d
Sonopet iQ Ultrasonic Aspirator System (5500-050-000)
K243930 · LFL Instrument, Ultrasonic... · General & Plastic Surgery
Mar 2025 94d
Consolidated Operating Room Equipment (CORE) 2 Console
K243958 · OLO Orthopedic Stereotaxic... · Orthopedic
Mar 2025 88d
iBur 3.0mm Diamond Match Head, Distal Bend (8431-107-030D); iBur 3.0mm Precision Round, Distal Bend (8431-009-030); iBur 4.0mm Precision Round, Distal Bend (8431-009-040); iBur 2.0mm Diamond Round, Distal Bend (8431-012-020D); iBur 3.0mm Diamond Round, Distal Bend (8431-012-030D); iBur 4.0mm Diamond Round, Distal Bend (8431-012-040D); iBur 3.0mm Coarse Diamond Round, Distal Bend (8431-013-030DC); iBur 4.0mm Coarse Diamond Round, Distal Bend (8431-013-040DC); iBur 5.0mm Coarse Diamond R
K250374 · HBE Drills, Burrs, Trephines... · Neurology
Mar 2025 29d
System 9 Sterile Battery Container
K242834 · KCT Sterilization Wrap... · General Hospital
Jan 2025 119d
PhotonBlade 3; PhotonBlade 3 Smoke Evacuation
K242266 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Oct 2024 81d
Stryker Steri-Shield 8 Surgical Hoods and Togas
K241272 · FYA Gown, Surgical · General Hospital
Oct 2024 163d
POWEReam Xia/Serrato
K240526 · NKB Thoracolumbosacral... · Orthopedic
Apr 2024 66d
SurgiCount+ System
K232250 · PBZ Image Processing Device... · General & Plastic Surgery
Jan 2024 167d
POWEReam 1/4 Drive
K233300 · NKB Thoracolumbosacral... · Orthopedic
Dec 2023 88d
SpineJack? Expansion Kit
K223294 · NDN Cement, Bone, Vertebroplasty · Orthopedic
Dec 2022 55d
120V Neptune S Rover (0711-001-000);V2 4-Port Manifold (0750-400-000);V2 Specimen Collection Manifold Kit (0750-200-000);V2 Specimen Collection Tray (0750-210-000)
K222552 · JCX Apparatus, Suction, Ward... · General & Plastic Surgery
Dec 2022 108d
SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV Radiopaque Bone Cement
K211238 · NDN Cement, Bone, Vertebroplasty · Orthopedic
Jun 2021 60d
Stryker Integrated Bipolar Cord and Tubing Sets
K172367 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Aug 2017 18d
STRYKER T6 HOODS AND TOGAS
K063005 · FYA Gown, Surgical · General Hospital
Mar 2007 172d
STRYKER NAVIGATION SYSTEM - CRANIAL MODULE, MODEL 6000-650-000
K062640 · HAW Neurological Stereotaxic... · Neurology
Dec 2006 99d
STRYKER ARIA PNEUMATIC SYSTEM
K061725 · HBB Motor, Drill, Pneumatic · Neurology
Oct 2006 129d
STRYKER RF PARALLEL BIPOLAR ADAPTOR CABLE
K061660 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Oct 2006 119d
STRYKER SILVERGLIDE BIPOLAR FORCEPS REUSABLE CABLE; DISPOSABLE CABLE
K061835 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Sep 2006 71d
STRYKER RF COAXIAL BIPOLAR ELECTRODES & CANNULAE
K043442 · GXI Probe, Radiofrequency Lesion · Neurology
May 2005 168d
STRYKER DISCMONITOR
K050753 · FMF Syringe, Piston · General Hospital
May 2005 56d
PAINPUMP2
K043466 · FRN Pump, Infusion · General Hospital
May 2005 146d
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