OSSEOFLEX SB INFLATABLE BONE TAMP

Cement, Bone, Vertebroplasty

OSSEON THERAPEUTICS, INC.

The following data is part of a premarket notification filed by Osseon Therapeutics, Inc. with the FDA for Osseoflex Sb Inflatable Bone Tamp.

Pre-market Notification Details

Device IDK122533
510k NumberK122533
Device Name:OSSEOFLEX SB INFLATABLE BONE TAMP
ClassificationCement, Bone, Vertebroplasty
Applicant OSSEON THERAPEUTICS, INC. 2330 CIRCADIAN WAY Santa Rosa,  CA  95407
ContactKeith Burger
CorrespondentKeith Burger
OSSEON THERAPEUTICS, INC. 2330 CIRCADIAN WAY Santa Rosa,  CA  95407
Product CodeNDN  
CFR Regulation Number888.3027 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-08-20
Decision Date2012-10-23
Summary:summary

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