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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Jeil Medical Corporation. It received FDA 510(k) clearance on 2017-02-23 under 510(k) 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. The listed applicant is Jeil Medical Corporation. The 510(k) number is K161335.

When did Dual Top Screw System receive FDA 510(k) clearance?

Dual Top Screw System received FDA 510(k) clearance on 2017-02-23, under 510(k) number K161335.

Who is the listed applicant for Dual Top Screw System?

The FDA 510(k) record lists Jeil Medical Corporation as the applicant. This does not by itself establish the device manufacturer.

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.

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