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FDA 510(k)

Codman Certas Plus Electronic Tool Kit

K-Number: K181902 · 2018-10-25

ApplicantIntegra Lifesciences Corp.
Decision Date2018-10-25
Product CodeJXG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Codman Certas Plus Electronic Tool Kit is the device name listed in this FDA 510(k) record. The listed applicant is Integra Lifesciences Corp.. It received FDA 510(k) clearance on 2018-10-25 under 510(k) number K181902. The device is classified under product code JXG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Codman Certas Plus Electronic Tool Kit?

Codman Certas Plus Electronic Tool Kit is a medical device that received FDA 510(k) clearance on 2018-10-25. The listed applicant is Integra Lifesciences Corp.. The 510(k) number is K181902.

When did Codman Certas Plus Electronic Tool Kit receive FDA 510(k) clearance?

Codman Certas Plus Electronic Tool Kit received FDA 510(k) clearance on 2018-10-25, under 510(k) number K181902.

Who is the listed applicant for Codman Certas Plus Electronic Tool Kit?

The FDA 510(k) record lists Integra Lifesciences Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Codman Certas Plus Electronic Tool Kit?

The FDA product code for Codman Certas Plus Electronic Tool Kit is JXG.

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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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