OSFERION

Filler, Bone Void, Calcium Compound

OLYMPUS TERUMO BIOMATERIALS CORPORATION

The following data is part of a premarket notification filed by Olympus Terumo Biomaterials Corporation with the FDA for Osferion.

Pre-market Notification Details

Device IDK080065
510k NumberK080065
Device Name:OSFERION
ClassificationFiller, Bone Void, Calcium Compound
Applicant OLYMPUS TERUMO BIOMATERIALS CORPORATION 3500 CORPORATE PARKWAY PO BOX 610 Center Valley,  PA  18034 -0610
ContactLaura Storms-tyler
CorrespondentLaura Storms-tyler
OLYMPUS TERUMO BIOMATERIALS CORPORATION 3500 CORPORATE PARKWAY PO BOX 610 Center Valley,  PA  18034 -0610
Product CodeMQV  
CFR Regulation Number888.3045 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-01-10
Decision Date2008-05-02
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04560245656975 K080065 000
04560245656968 K080065 000
04560245656951 K080065 000
04560245656913 K080065 000
04560245656906 K080065 000
04560245656890 K080065 000
04560245656883 K080065 000

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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