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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 K201966
Device Name 7D Surgical FlashLock 1, 7D Surgical Flex Rod Connector - 5.5 mm - 150 mm, 7D Surgical Flex Array
Applicant
7D Surgical Inc.
60 Scarsdale Road, Unit 118
Toronto,  CA M3B 2R7
Applicant Contact Daniel Zisind
Correspondent
7D Surgical Inc.
60 Scarsdale Road, Unit 118
Toronto,  CA M3B 2R7
Correspondent Contact Daniel Ziskind
Regulation Number882.4560
Classification Product Code
OLO  
Date Received07/15/2020
Decision Date 09/03/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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