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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 K260403
Device Name 7D Surgical System (10-0001)
Applicant
7D Surgical ULC
60 Scarsdale Rd., Unit 118
Toronto,  CA M3B 2R7
Applicant Contact Elena Marenny
Correspondent
7D Surgical ULC
60 Scarsdale Rd., Unit 118
Toronto,  CA M3B 2R7
Correspondent Contact Elena Marenny
Regulation Number882.4560
Classification Product Code
OLO  
Date Received02/06/2026
Decision Date 10/19/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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