Medical Device Manufacturer · US , Kalamazoo , MI

Stryker Instruments - FDA 510(k) Cleared Devices

73 submissions · 73 cleared · Since 1994

Recent clearances: Hydro Irrigation System, SurgiCount+ System, RPS Primary TKA Software

73

Total

73

Cleared

0

Denied

FDA 510(k) Regulatory Record - Stryker Instruments Orthopedic ✕

10 devices

1-10 of 10

Cleared Sep 25, 2025

RPS Primary TKA Software

Orthopedic · 91d

Cleared Mar 21, 2025

Consolidated Operating Room Equipment (CORE) 2 Console

Orthopedic · 88d

Cleared Apr 29, 2024

POWEReam Xia/Serrato

Orthopedic · 66d

Cleared Dec 26, 2023

POWEReam 1/4 Drive

Orthopedic · 88d

Cleared Dec 20, 2022

SpineJack® Expansion Kit

Orthopedic · 55d

Cleared Jun 25, 2021

SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV...

Orthopedic · 60d

Cleared Nov 07, 2003

DEKOMPRESSOR PERCUTANEOUS DISCECTOMY PROBE

Orthopedic · 87d

Cleared Nov 19, 1999

STRYKER LEIBINGER RESORBABLE FIXATION SYSTEM

Orthopedic · 67d

Cleared Sep 04, 1997

STRYKER SYSTEM 4000 HEAVY DUTY BATTERY POWERED EQUIPMENT

Orthopedic · 71d

Cleared Sep 11, 1996

STRYKER UNIVERSAL DRILL ATTACHMENTS & ACCESSORIES

Orthopedic · 55d