Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2249915

FEI Number

3002600221

Entity Name

OSTEOTECH, INC.

City/State/Country

EATONTOWN, NJ, US

Establishment Address

201 Industrial Way West, EATONTOWN, NJ 07724, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Medtronic, Inc. (Owner Number: 2112641)

Owner / Operator Contact Address

710 Medtronic Parkway, Minneapolis, MN 55432, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K122513

PMA Number

N/A

All Registered Proprietary Names

Plexur P Grafton II eDBM MagniFuse Bone Graft MagniFuse Graft Delivery Device with Integrated Stylet Syringe, Piston Grafton DBM Plus Grafton DBM Paste Grafton DBM Magnifuse II Bone Graft

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MBP	Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)	Orthopedic	Class 2	888.3045	2011-11-22
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2011-11-22
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2011-11-22
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2025-07-15
MBP	Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)	Orthopedic	Class 2	888.3045	2011-11-21
NUN	Bone Grafting Material, Human Source	Dental	Class 2	872.3930	2011-11-21
MBP	Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)	Orthopedic	Class 2	888.3045	2014-01-31
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2014-01-31

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Medtronic, Inc.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3007042319	HeartWare, Inc.	Miami Lakes, FL, US
3004497303	MEDTRONIC MEXICO EG	EMPALME Sonora, MX
3015192387	CATHWORKS	Newport Beach, CA, US
3004185781	Medtronic, Inc.	Tempe, AZ, US
3012520654	MEDTRONIC, INC.	Billerica, MA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K103464	Medtronic, Inc.	PACIFIC XTREME PTCA BALLOON DILATATION CATHETER	2010-12-22
K111339	Medtronic, Inc.	HEMOSTASIS MANAGMENT SYSTEM PLUS (HMS-PLUS)	2011-06-08
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

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0003-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 30G X 5/16'' syringes
Z-0004-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1 cc X 29G X 1/2 '' insulin syringes
Z-0005-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 29G X 1/2 '' insulin syringes
Z-0005-2024	Fresenius Medical Care Holdings, Inc.	2	10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0, 100 per box, 12 boxes to a case
Z-0006-2024	Fresenius Medical Care Holdings, Inc.	2	10ML SYRINGE LUER LOCK W/NEEDLE, Part Number 15-10ML-0, 100 per box, 12 boxes per case

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2249915. Last updated year: 2026. Please use registration number 2249915 when referencing this establishment in official correspondence.