Bone Screw, Bone Tack
K-Number: K182881 · 2019-08-09
ApplicantOsstem Implant Co., Ltd.
Decision Date2019-08-09
Product CodeDZL
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Bone Screw, Bone Tack is a medical device manufactured by Osstem Implant Co., Ltd.. It received FDA 510(k) clearance on 2019-08-09 under approval number K182881. 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 Bone Screw, Bone Tack?
Bone Screw, Bone Tack is a medical device that received FDA 510(k) clearance on 2019-08-09. It is manufactured by Osstem Implant Co., Ltd.. The 510(k) number is K182881.
When was Bone Screw, Bone Tack approved by the FDA?
Bone Screw, Bone Tack received FDA 510(k) clearance on 2019-08-09, under approval number K182881.
What company makes Bone Screw, Bone Tack?
Bone Screw, Bone Tack is manufactured by Osstem Implant Co., Ltd..
What is the FDA product code for Bone Screw, Bone Tack?
The FDA product code for Bone Screw, Bone Tack is DZL.
Other Devices by Osstem Implant Co., Ltd.
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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.