CYTOPLAST REGENTEX TITANIUM 250

Bone Grafting Material, Synthetic

OSTEOGENICS CO.

The following data is part of a premarket notification filed by Osteogenics Co. with the FDA for Cytoplast Regentex Titanium 250.

Pre-market Notification Details

Device IDK972278
510k NumberK972278
Device Name:CYTOPLAST REGENTEX TITANIUM 250
ClassificationBone Grafting Material, Synthetic
Applicant OSTEOGENICS CO. 6401 MEADOWS WEST DR. Fort Worth,  TX  76132
ContactRichard A Hamer
CorrespondentRichard A Hamer
OSTEOGENICS CO. 6401 MEADOWS WEST DR. Fort Worth,  TX  76132
Product CodeLYC  
CFR Regulation Number872.3930 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-06-18
Decision Date1997-08-06
Summary:summary

NIH GUDID Devices

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