NORIAN XR CALCIUM PHOSPHATE BONE VOID FILLER

Filler, Bone Void, Calcium Compound

SYNTHES (USA)

The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Norian Xr Calcium Phosphate Bone Void Filler.

Pre-market Notification Details

Device IDK023862
510k NumberK023862
Device Name:NORIAN XR CALCIUM PHOSPHATE BONE VOID FILLER
ClassificationFiller, Bone Void, Calcium Compound
Applicant SYNTHES (USA) 1690 RUSSELL RD. Paoli,  PA  19301
ContactVikki M Hoffman
CorrespondentVikki M Hoffman
SYNTHES (USA) 1690 RUSSELL RD. Paoli,  PA  19301
Product CodeMQV  
CFR Regulation Number888.3045 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-11-20
Decision Date2002-12-19
Summary:summary

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