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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drills, Burrs, Trephines & Accessories (Simple, Powered)
510(k) Number K232684
Device Name Surgify Halo
Applicant
Surgify Medical OY
Otakaari 5
Espoo,  FI 02150
Applicant Contact Jukka Kreander
Correspondent
Maxis Medical LLC
3031 Tisch Way Suite 1010
San Jose,  CA  95128
Correspondent Contact Sujith Shetty
Regulation Number882.4310
Classification Product Code
HBE  
Date Received09/01/2023
Decision Date 11/29/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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