Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011121816

FEI Number

3011121816

Entity Name

OSTEONOVUS, INC.

City/State/Country

Toledo, OH, US

Establishment Address

1510 N. Westwood Ave., Suite 1070, Toledo, OH 43606, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

OsteoNovus, Inc. (Owner Number: 10054994)

Owner / Operator Contact Address

1510 N. Westwood Ave., Suite 1070, Toledo, OH 43606, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K162087

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

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	2018-06-13
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2017-05-23

Official Correspondent

Anand Agarwal

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

OsteoNovus, Inc.

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

Similar Registrations

Registration Number	Establishment Name	Location
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3019403037	HERAEUS MEDICAL LLC - BIORESOBABLES	Yardley, PA, US
3010376334	GEV Co., Ltd.	Eumseong-gun Chungbuk, KR
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 3011121816. Last updated year: 2026. Please use registration number 3011121816 when referencing this establishment in official correspondence.