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FDA 510(k)

JNE IMPLANT SYSTEM

K-Number: K072425 · 2008-03-10

ApplicantGC America, Inc.
Decision Date2008-03-10
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

JNE IMPLANT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is GC America, Inc.. It received FDA 510(k) clearance on 2008-03-10 under 510(k) number K072425. 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 JNE IMPLANT SYSTEM?

JNE IMPLANT SYSTEM is a medical device that received FDA 510(k) clearance on 2008-03-10. The listed applicant is GC America, Inc.. The 510(k) number is K072425.

When did JNE IMPLANT SYSTEM receive FDA 510(k) clearance?

JNE IMPLANT SYSTEM received FDA 510(k) clearance on 2008-03-10, under 510(k) number K072425.

Who is the listed applicant for JNE IMPLANT SYSTEM?

The FDA 510(k) record lists GC America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for JNE IMPLANT SYSTEM?

The FDA product code for JNE IMPLANT SYSTEM is DZE.

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Related Devices (Code: DZE)

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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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