DYNAGRAFT II

Filler, Bone Void, Calcium Compound

ISOTIS ORTHOBIOLOGICS, INC

The following data is part of a premarket notification filed by Isotis Orthobiologics, Inc with the FDA for Dynagraft Ii.

Pre-market Notification Details

Device IDK040419
510k NumberK040419
Device Name:DYNAGRAFT II
ClassificationFiller, Bone Void, Calcium Compound
Applicant ISOTIS ORTHOBIOLOGICS, INC PROF. BRONKHORSTLAAN 10-D P.O. BOX 98 Bilthoven,  NL 3723 Mb
ContactEliane Schutte
CorrespondentEliane Schutte
ISOTIS ORTHOBIOLOGICS, INC PROF. BRONKHORSTLAAN 10-D P.O. BOX 98 Bilthoven,  NL 3723 Mb
Product CodeMQV  
CFR Regulation Number888.3045 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-02-18
Decision Date2005-03-25
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10889981153649 K040419 000
M3860220100501 K040419 000
M3860220100251 K040419 000
M3860220100101 K040419 000
M3860220001001 K040419 000
M3860220000501 K040419 000
M3860220000101 K040419 000
M3860220000051 K040419 000
M386TXG011 K040419 000
M386TXP101 K040419 000
M386TXP051 K040419 000
M386TXG101 K040419 000
M3860220101001 K040419 000
M386562000101 K040419 000
M386562000501 K040419 000
10889981153632 K040419 000
10889981153625 K040419 000
10889981153618 K040419 000
10889981153601 K040419 000
10889981153595 K040419 000
10889981153588 K040419 000
M386562101001 K040419 000
M386562100501 K040419 000
M386562100251 K040419 000
M386562100101 K040419 000
M386562001001 K040419 000
M386TXG051 K040419 000

Trademark Results [DYNAGRAFT II]

Mark Image

Registration | Serial
Company
Trademark
Application Date
DYNAGRAFT II
DYNAGRAFT II
76427651 not registered Dead/Abandoned
GenSci OrthoBiologics, Inc.
2002-07-05

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