SMARTBUILDER SYSTEM (SB1)

Plate, Bone

OSSTEM IMPLANT CO.,LTD

The following data is part of a premarket notification filed by Osstem Implant Co.,ltd with the FDA for Smartbuilder System (sb1).

Pre-market Notification Details

Device IDK130840
510k NumberK130840
Device Name:SMARTBUILDER SYSTEM (SB1)
ClassificationPlate, Bone
Applicant OSSTEM IMPLANT CO.,LTD 85 BEN FAIRLESS DR. Fairless Hills,  PA  19030
ContactPatrick Lim
CorrespondentPatrick Lim
OSSTEM IMPLANT CO.,LTD 85 BEN FAIRLESS DR. Fairless Hills,  PA  19030
Product CodeJEY  
CFR Regulation Number872.4760 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-03-27
Decision Date2013-09-18
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08800000925233 K130840 000
08800000925134 K130840 000
08800000925141 K130840 000
08800000925158 K130840 000
08800000925165 K130840 000
08800000925172 K130840 000
08800000925189 K130840 000
08800000925196 K130840 000
08800000925202 K130840 000
08800000925219 K130840 000
08800000925226 K130840 000
08800000925127 K130840 000

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