ORTHOBLAST II DBM DEMINERALIZED BONE MATRIX PASTE AND PUTTY

Bone Grafting Material, Human Source

ISOTIS NV

The following data is part of a premarket notification filed by Isotis Nv with the FDA for Orthoblast Ii Dbm Demineralized Bone Matrix Paste And Putty.

Pre-market Notification Details

Device IDK060332
510k NumberK060332
Device Name:ORTHOBLAST II DBM DEMINERALIZED BONE MATRIX PASTE AND PUTTY
ClassificationBone Grafting Material, Human Source
Applicant ISOTIS NV PROF. BRONKHORSTLAAN 10-D Bilthoven,  NL 3723 Mb
ContactEliane Schutte
CorrespondentEliane Schutte
ISOTIS NV PROF. BRONKHORSTLAAN 10-D Bilthoven,  NL 3723 Mb
Product CodeNUN  
CFR Regulation Number872.3930 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-02-09
Decision Date2006-03-29
Summary:summary

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