NORIAN DRILLABLE

Calcium Salt Bone Void Filler, Drillable, Non-screw Augmentation

SYNTHES (USA)

The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Norian Drillable.

Pre-market Notification Details

Device IDK073303
510k NumberK073303
Device Name:NORIAN DRILLABLE
ClassificationCalcium Salt Bone Void Filler, Drillable, Non-screw Augmentation
Applicant SYNTHES (USA) 1230 WILSON DRIVE West Chester,  PA  19380
ContactJeffrey L Dow
CorrespondentJeffrey L Dow
SYNTHES (USA) 1230 WILSON DRIVE West Chester,  PA  19380
Product CodeOIS  
CFR Regulation Number888.3045 [🔎]
DecisionSe - With Limitations (SESU)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-11-23
Decision Date2008-07-02
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
H67907704110S0 K073303 000
H67907704105S0 K073303 000
H67907704103S0 K073303 000
H67907704010S0 K073303 000
H67907704005S0 K073303 000
H67907704003S0 K073303 000

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