OssBuilder System
K-Number: K172354 · 2018-03-26
ApplicantOsstem Implant Co., Ltd.
Decision Date2018-03-26
Product CodeJEY
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
OssBuilder System is a medical device manufactured by Osstem Implant Co., Ltd.. It received FDA 510(k) clearance on 2018-03-26 under approval number K172354. The device is classified under product code JEY. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the OssBuilder System?
OssBuilder System is a medical device that received FDA 510(k) clearance on 2018-03-26. It is manufactured by Osstem Implant Co., Ltd.. The 510(k) number is K172354.
When was OssBuilder System approved by the FDA?
OssBuilder System received FDA 510(k) clearance on 2018-03-26, under approval number K172354.
What company makes OssBuilder System?
OssBuilder System is manufactured by Osstem Implant Co., Ltd..
What is the FDA product code for OssBuilder System?
The FDA product code for OssBuilder System is JEY.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.