FDA 510(k)

ORTHOCORD

K-Number: K123668 · 2013-02-26

ApplicantDepuy Mitek, Inc., A Johnson and Johnson Company

Decision Date2013-02-26

Product CodeNEW

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

ORTHOCORD is the device name listed in this FDA 510(k) record. The listed applicant is Depuy Mitek, Inc., A Johnson and Johnson Company. It received FDA 510(k) clearance on 2013-02-26 under 510(k) number K123668. The device is classified under product code NEW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORTHOCORD?

ORTHOCORD is a medical device that received FDA 510(k) clearance on 2013-02-26. The listed applicant is Depuy Mitek, Inc., A Johnson and Johnson Company. The 510(k) number is K123668.

When did ORTHOCORD receive FDA 510(k) clearance?

ORTHOCORD received FDA 510(k) clearance on 2013-02-26, under 510(k) number K123668.

Who is the listed applicant for ORTHOCORD?

The FDA 510(k) record lists Depuy Mitek, Inc., A Johnson and Johnson Company as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ORTHOCORD?

The FDA product code for ORTHOCORD is NEW.

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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.