ReBOSSIS85

Filler, Bone Void, Calcium Compound

Orthorebirth Co., Ltd.

The following data is part of a premarket notification filed by Orthorebirth Co., Ltd. with the FDA for Rebossis85.

Pre-market Notification Details

Device IDK172573
510k NumberK172573
Device Name:ReBOSSIS85
ClassificationFiller, Bone Void, Calcium Compound
Applicant Orthorebirth Co., Ltd. 3-17-43 Chigasaki Higashi Tsuzuki-ku Yokohama,  JP 224-0033
ContactYasutoshi Nishikawa
CorrespondentKevin A. Thomas
PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego,  CA  92130
Product CodeMQV  
CFR Regulation Number888.3045 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-08-28
Decision Date2017-12-15
Summary:summary

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