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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthopedic Stereotaxic Instrument
510(k) Number K243958
Device Name Consolidated Operating Room Equipment (CORE) 2 Console
Applicant
Stryker Instruments
1941 Stryker Way
Kalamazoo,  MI  49002
Applicant Contact Leandra Burke
Correspondent
Stryker Instruments
1941 Stryker Way
Kalamazoo,  MI  49002
Correspondent Contact Leandra Burke
Regulation Number882.4560
Classification Product Code
OLO  
Subsequent Product Codes
ERL   HBE   HWE  
Date Received12/23/2024
Decision Date 03/21/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
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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