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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 K172573
Device Name ReBOSSIS85
Applicant
Orthorebirth Co., Ltd.
3-17-43 Chigasaki Higashi
tsuzuki-ku yokohama,  JP 224-0033
Applicant Contact yasutoshi nishikawa
Correspondent
PaxMed International, LLC
12264 El Camino Real, Suite 400
san diego,  CA  92130
Correspondent Contact kevin a. thomas
Regulation Number888.3045
Classification Product Code
MQV  
Date Received08/28/2017
Decision Date 12/15/2017
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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