OssBuilder System
K-Number: K181854 · 2019-05-07
ApplicantOsstem Implant Co., Ltd.
Decision Date2019-05-07
Product CodeDZL
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 2019-05-07 under approval number K181854. The device is classified under product code DZL. 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 2019-05-07. It is manufactured by Osstem Implant Co., Ltd.. The 510(k) number is K181854.
When was OssBuilder System approved by the FDA?
OssBuilder System received FDA 510(k) clearance on 2019-05-07, under approval number K181854.
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 DZL.
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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.