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FDA 510(k)

BICORTICAL SCREW

K-Number: K983120 · 1999-07-29

ApplicantOraltronics Marketing-Und Vertriebs GmbH
Decision Date1999-07-29
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BICORTICAL SCREW is the device name listed in this FDA 510(k) record. The listed applicant is Oraltronics Marketing-Und Vertriebs GmbH. It received FDA 510(k) clearance on 1999-07-29 under 510(k) number K983120. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BICORTICAL SCREW?

BICORTICAL SCREW is a medical device that received FDA 510(k) clearance on 1999-07-29. The listed applicant is Oraltronics Marketing-Und Vertriebs GmbH. The 510(k) number is K983120.

When did BICORTICAL SCREW receive FDA 510(k) clearance?

BICORTICAL SCREW received FDA 510(k) clearance on 1999-07-29, under 510(k) number K983120.

Who is the listed applicant for BICORTICAL SCREW?

The FDA 510(k) record lists Oraltronics Marketing-Und Vertriebs GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BICORTICAL SCREW?

The FDA product code for BICORTICAL SCREW is DZE.

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Related Devices (Code: DZE)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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