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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Intervertebral Fusion Device With Integrated Fixation, Lumbar
510(k) Number K201585
Device Name Monterey AL Interbody System
Applicant
Stryker Corporation
2 Pearl Court
Allendale,  NJ  07401
Applicant Contact Alexia Haralambous
Correspondent
Stryker Corporation
2 Pearl Court
Allendale,  NJ  07401
Correspondent Contact Alexia Haralambous
Regulation Number888.3080
Classification Product Code
OVD  
Subsequent Product Code
MAX  
Date Received06/11/2020
Decision Date 08/10/2020
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
Recalls CDRH Recalls
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