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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
510(k) Number K242834
Device Name System 9 Sterile Battery Container
Applicant
Stryker Instruments
1941 Stryker Way
Portage,  MI  49002
Applicant Contact Megan Guilbault
Correspondent
Stryker Instruments
1941 Stryker Way
Portage,  MI  49002
Correspondent Contact Megan Guilbault
Regulation Number880.6850
Classification Product Code
KCT  
Date Received09/19/2024
Decision Date 01/16/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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