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FDA 510(k)

D4000 DRIVE SYSTEM; D4000A DRIVE SYSTEM WITH IRRIGATION

K-Number: K130497 · 2013-03-29

ApplicantLinvatec Corporation D/B/A Conmed Linvatec
Decision Date2013-03-29
Product CodeHBC
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

D4000 DRIVE SYSTEM; D4000A DRIVE SYSTEM WITH IRRIGATION is the device name listed in this FDA 510(k) record. The listed applicant is Linvatec Corporation D/B/A Conmed Linvatec. It received FDA 510(k) clearance on 2013-03-29 under 510(k) number K130497. The device is classified under product code HBC. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the D4000 DRIVE SYSTEM; D4000A DRIVE SYSTEM WITH IRRIGATION?

D4000 DRIVE SYSTEM; D4000A DRIVE SYSTEM WITH IRRIGATION is a medical device that received FDA 510(k) clearance on 2013-03-29. The listed applicant is Linvatec Corporation D/B/A Conmed Linvatec. The 510(k) number is K130497.

When did D4000 DRIVE SYSTEM; D4000A DRIVE SYSTEM WITH IRRIGATION receive FDA 510(k) clearance?

D4000 DRIVE SYSTEM; D4000A DRIVE SYSTEM WITH IRRIGATION received FDA 510(k) clearance on 2013-03-29, under 510(k) number K130497.

Who is the listed applicant for D4000 DRIVE SYSTEM; D4000A DRIVE SYSTEM WITH IRRIGATION?

The FDA 510(k) record lists Linvatec Corporation D/B/A Conmed Linvatec as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for D4000 DRIVE SYSTEM; D4000A DRIVE SYSTEM WITH IRRIGATION?

The FDA product code for D4000 DRIVE SYSTEM; D4000A DRIVE SYSTEM WITH IRRIGATION is HBC.

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Other records listing Linvatec Corporation D/B/A Conmed Linvatec as applicant

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Related Devices (Code: HBC)

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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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