PLEXUR-P

Filler, Bone Void, Calcium Compound

OSTEOTECH, INC.

The following data is part of a premarket notification filed by Osteotech, Inc. with the FDA for Plexur-p.

Pre-market Notification Details

Device IDK080511
510k NumberK080511
Device Name:PLEXUR-P
ClassificationFiller, Bone Void, Calcium Compound
Applicant OSTEOTECH, INC. 51 JAMES WAY Eatontown,  NJ  07724
ContactChris Talbot
CorrespondentChris Talbot
OSTEOTECH, INC. 51 JAMES WAY Eatontown,  NJ  07724
Product CodeMQV  
CFR Regulation Number888.3045 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-02-25
Decision Date2008-04-21
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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00643169218086 K080511 000
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00643169218116 K080511 000
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00643169218222 K080511 000
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00643169218253 K080511 000
00643169218260 K080511 000
00643169218277 K080511 000
00643169218284 K080511 000
00643169218062 K080511 000

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