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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 K241082
Device Name INNOVERSE Navigation Instruments
Applicant
Innosys Co., Ltd.
20, Sandan-Ro 76beon-Gil (Rd)
Uijeongbu-Si,  KR 11781
Applicant Contact Hye-Kyung Lee
Correspondent
Empirical Technologies
4628 Northpark Dr.
Colorado Springs,  CO  80918
Correspondent Contact Nathan Wright
Regulation Number882.4560
Classification Product Code
OLO  
Subsequent Product Code
NKB  
Date Received04/19/2024
Decision Date 06/14/2024
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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