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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 K171525
Device Name Intellijoint HIP Generation 2B System
Applicant
Intellijoint Surgical, Inc.
60 Bathurst Dr.
Unit 6
Waterloo,  CA N2V 2A9
Applicant Contact Brandon Gingrich
Correspondent
Intellijoint Surgical, Inc.
60 Bathurst Dr.
Unit 6
Waterloo,  CA N2V 2A9
Correspondent Contact Brandon Gingrich
Regulation Number882.4560
Classification Product Code
OLO  
Date Received05/25/2017
Decision Date 10/30/2017
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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