CORTOSS BONE AUGMENTATION MATERIAL

Cement, Bone, Vertebroplasty

ORTHOVITA, INC.

The following data is part of a premarket notification filed by Orthovita, Inc. with the FDA for Cortoss Bone Augmentation Material.

Pre-market Notification Details

Device IDK080108
510k NumberK080108
Device Name:CORTOSS BONE AUGMENTATION MATERIAL
ClassificationCement, Bone, Vertebroplasty
Applicant ORTHOVITA, INC. 45 GREAT VALLEY PKWY. Malvern,  PA  19355
ContactGina M Nagvajara
CorrespondentGina M Nagvajara
ORTHOVITA, INC. 45 GREAT VALLEY PKWY. Malvern,  PA  19355
Product CodeNDN  
CFR Regulation Number888.3027 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-01-15
Decision Date2009-06-05
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
30808232000949 K080108 000
00808232001372 K080108 000
00808232000979 K080108 000
00808232000962 K080108 000
00808232000917 K080108 000

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