OSSEOFLEX SB, 10G/4ML, OSSEOFLEX SB, 10G/2ML

Cement, Bone, Vertebroplasty

OSSEON LLC

The following data is part of a premarket notification filed by Osseon Llc with the FDA for Osseoflex Sb, 10g/4ml, Osseoflex Sb, 10g/2ml.

Pre-market Notification Details

Device IDK141930
510k NumberK141930
Device Name:OSSEOFLEX SB, 10G/4ML, OSSEOFLEX SB, 10G/2ML
ClassificationCement, Bone, Vertebroplasty
Applicant OSSEON LLC 2330 CIRCADIAN WAY Santa Rosa,  CA  95407
ContactKeith Burger
CorrespondentKeith Burger
OSSEON LLC 2330 CIRCADIAN WAY Santa Rosa,  CA  95407
Product CodeNDN  
CFR Regulation Number888.3027 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-07-16
Decision Date2014-08-21
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00884450327913 K141930 000
00884450327906 K141930 000
10884450386757 K141930 000
10884450386740 K141930 000

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