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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 K220554
Device Name Caduceus S
Applicant
Taiwan Main Orthopaedic Biotechnology Co., Ltd.
1F., No. 46, Keya Rd., Daya Dist.
Taichung City,  TW 428
Applicant Contact Jacky Fan
Correspondent
Taiwan Main Orthopaedic Biotechnology Co., Ltd.
1F., No. 46, Keya Rd., Daya Dist.
Taichung City,  TW 428
Correspondent Contact Jacky Fan
Regulation Number882.4560
Classification Product Code
OLO  
Date Received02/28/2022
Decision Date 12/16/2022
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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