Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007738819

FEI Number

3007738819

Entity Name

OSferionBiomaterials Corp. Mishima Factory

City/State/Country

Sunto-gun Shizuoka, JP

Establishment Address

454-1 Higashino, Nagaizumi-cho, Sunto-gun Shizuoka 411-0931, JP

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

OSferionBiomaterials Corp. (Owner Number: 9087979)

Owner / Operator Contact Address

1-50-1 Sasazuka, Shibuya-ku, JP-13 151-0073, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K080065

PMA Number

N/A

All Registered Proprietary Names

OSferion

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	2008-08-27

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar corp Email: David.Lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

OSferionBiomaterials Corp.

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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3016050940	Olive Branch Distribution Center	Olive Branch, MS, US
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007738819. Last updated year: 2026. Please use registration number 3007738819 when referencing this establishment in official correspondence.