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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Rod, Fixation, Intramedullary And Accessories
510(k) Number K222309
Device Name Gamma4 System
Applicant
Stryker GmbH
325 Corporate Dr.
Mahwah,  NJ  07430
Applicant Contact Cindy Leon
Correspondent
Stryker GmbH
325 Corporate Dr.
Mahwah,  NJ  07430
Correspondent Contact Cindy Leon
Regulation Number888.3020
Classification Product Code
HSB  
Date Received08/01/2022
Decision Date 11/15/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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