Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011415547

FEI Number

3011415547

Entity Name

ORTHOREBIRTH CO., LTD.

City/State/Country

Yokohama Kanagawa, JP

Establishment Address

15-3-303, Chigasaki-chuo, Tsuzuki-ku, Yokohama Kanagawa 224-0032, JP

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

ORTHOREBIRTH Co., Ltd. (Owner Number: 10048526)

Owner / Operator Contact Address

3-17-43 Chigaski-Higashi, Tsuzukiku, Yokohama, JP-14 224-0033, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K170620

PMA Number

N/A

All Registered Proprietary Names

ReBOSSIS ReBOSSIS QDS

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2017-09-08

Official Correspondent

No official correspondent registered.

US Agent Details

Floyd Larson Business: PAXMED INTERNATIONAL, LLC Email: flarson@paxmed.com Phone: (858) 7921235

Related Public Records

Same Entity

ORTHOREBIRTH Co., Ltd.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K180121	Cellumed Co., Ltd.	Rafugen DBM	2018-04-11
K062691	Takiron Co., Ltd.	COMPORUS	2008-04-15
K023703	Berkeley Advanced Biomaterials, Inc.	BI-OSTETIC	2003-01-30
K173933	Xenco Medical, LLC	Sorrento Bioglass Bone Graft Substitute	2018-09-13

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3043620406	REVOGEN BIOLOGICS	San Antonio, TX, US
3016050940	Olive Branch Distribution Center	Olive Branch, MS, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011415547. Last updated year: 2026. Please use registration number 3011415547 when referencing this establishment in official correspondence.