Dual Top Screw System
K-Number: K161335 · 2017-02-23
ApplicantJeil Medical Corporation
Decision Date2017-02-23
Product CodeOAT
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Dual Top Screw System is a medical device manufactured by Jeil Medical Corporation. It received FDA 510(k) clearance on 2017-02-23 under approval number K161335. The device is classified under product code OAT. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Dual Top Screw System?
Dual Top Screw System is a medical device that received FDA 510(k) clearance on 2017-02-23. It is manufactured by Jeil Medical Corporation. The 510(k) number is K161335.
When was Dual Top Screw System approved by the FDA?
Dual Top Screw System received FDA 510(k) clearance on 2017-02-23, under approval number K161335.
What company makes Dual Top Screw System?
Dual Top Screw System is manufactured by Jeil Medical Corporation.
What is the FDA product code for Dual Top Screw System?
The FDA product code for Dual Top Screw System is OAT.
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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.