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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 K222753
Device Name SeaSpine 7D Navigation Instruments
Applicant
SeaSpine Orthopedics Corporation
5770 Armada Dr.
Carlsbad,  CA  92008
Applicant Contact Laeitia Cousin
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 Received09/12/2022
Decision Date 12/09/2022
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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