REBOSSIS

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 Rebossis.

Pre-market Notification Details

Device IDK142090
510k NumberK142090
Device Name:REBOSSIS
ClassificationFiller, Bone Void, Calcium Compound
Applicant ORTHOREBIRTH CO., LTD. 12264 El Camino Real, Suite 400 San Diego,  CA  92130
ContactKevin A.thomas
CorrespondentKevin A.thomas
ORTHOREBIRTH CO., LTD. 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 Received2014-08-01
Decision Date2014-10-29
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04573190050231 K142090 000
04573190050224 K142090 000
04573190050132 K142090 000
04573190050125 K142090 000
04573190050118 K142090 000
04573190050033 K142090 000
04573190050026 K142090 000
04573190050019 K142090 000

Trademark Results [REBOSSIS]

Mark Image

Registration | Serial
Company
Trademark
Application Date
REBOSSIS
REBOSSIS
85602550 4564667 Live/Registered
Orthorebirth Co., Ltd.
2012-04-19
REBOSSIS
REBOSSIS
79232932 5694086 Live/Registered
ORTHOREBIRTH CO., LTD.
2018-03-07

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