OSferion AR-13370-2

GUDID 04560245656890

OSferion is a white porous material composed of β-tricalcium phosphate. It is intended to fill bony voids or gaps caused by trauma or surgery that are

OLYMPUS TERUMO BIOMATERIALS CORP.

Bone matrix implant, synthetic
Primary Device ID04560245656890
NIH Device Record Key996e11ae-5b07-4986-b383-b17f875d2c13
Commercial Distribution StatusIn Commercial Distribution
Brand NameOSferion
Version Model NumberAR-13370-2
Catalog NumberAR-13370-2
Company DUNS697730638
Company NameOLYMPUS TERUMO BIOMATERIALS CORP.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800-934-4404
Emailcomplaints@arthrex.com

Device Dimensions

Length12 Millimeter
Length30 Millimeter
Length3 Millimeter
Length10 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS104560245656890 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MQVFiller, Bone Void, Calcium Compound

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-09-24

On-Brand Devices [OSferion]

04560245656975OSferion is a white porous material composed of β-tricalcium phosphate. It is intended to fill
04560245656968OSferion is a white porous material composed of β-tricalcium phosphate. It is intended to fill
04560245656951OSferion is a white porous material composed of β-tricalcium phosphate. It is intended to fill
04560245656913OSferion is a white porous material composed of β-tricalcium phosphate. It is intended to fill
04560245656906OSferion is a white porous material composed of β-tricalcium phosphate. It is intended to fill
04560245656890OSferion is a white porous material composed of β-tricalcium phosphate. It is intended to fill
04560245656883OSferion is a white porous material composed of β-tricalcium phosphate. It is intended to fill

Trademark Results [OSferion]

Mark Image

Registration | Serial
Company
Trademark
Application Date
OSFERION
OSFERION
86801089 not registered Dead/Abandoned
Olympus Terumo Biomaterials Corp.
2015-10-27
OSFERION
OSFERION
85446686 not registered Dead/Abandoned
Olympus Terumo Biomaterials Corp.
2011-10-13
OSFERION
OSFERION
78864467 3332489 Live/Registered
OLYMPUS TERUMO BIOMATERIALS CORPORATION
2006-04-19
OSFERION
OSFERION
78864465 3332488 Live/Registered
OLYMPUS TERUMO BIOMATERIALS CORPORATION
2006-04-19
OSFERION
OSFERION
78160576 not registered Dead/Abandoned
Olympus Corporation
2002-09-04
OSFERION
OSFERION
77308218 not registered Dead/Abandoned
Olympus Terumo Biomaterials Corp.
2007-10-19
OSFERION
OSFERION
75450676 not registered Dead/Abandoned
OLYMPUS OPTICAL COMPANY LIMITED
1998-03-16

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