GRAFTON PLUS DBM PASTE

Filler, Bone Void, Osteoinduction (w/o Human Growth Factor)

OSTEOTECH, INC.

The following data is part of a premarket notification filed by Osteotech, Inc. with the FDA for Grafton Plus Dbm Paste.

Pre-market Notification Details

Device IDK043048
510k NumberK043048
Device Name:GRAFTON PLUS DBM PASTE
ClassificationFiller, Bone Void, Osteoinduction (w/o Human Growth Factor)
Applicant OSTEOTECH, INC. 51 JAMES WAY Eatontown,  NJ  07724
ContactChristopher Talbot
CorrespondentChristopher Talbot
OSTEOTECH, INC. 51 JAMES WAY Eatontown,  NJ  07724
Product CodeMBP  
CFR Regulation Number888.3045 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-11-04
Decision Date2005-11-23
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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00613994985651 K043048 000
00613994985668 K043048 000
00613994986191 K043048 000
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00613994986214 K043048 000
00643169122949 K043048 000
00643169123021 K043048 000
00643169123038 K043048 000
00643169134324 K043048 000
00643169134379 K043048 000
00643169134386 K043048 000
00643169965096 K043048 000

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