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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Filler, Bone Void, Calcium Compound
510(k) Number K240453
Device Name ReBOSSIS
Applicant
Orthorebirth Co., Ltd.
3-17-43 Chigasaki Higashi
Yokohama,  JP 224-0033
Applicant Contact Yasutoshi Nishikawa
Correspondent
MCRA, LLC
803 7th St. NW
Washington,  DC  20001
Correspondent Contact Justin Eggleton
Regulation Number888.3045
Classification Product Code
MQV  
Date Received02/15/2024
Decision Date 03/04/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
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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