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FDA 510(k)

ZTI IMPLANTS SYSTEM, DRM IMPLANTS

K-Number: K034067 · 2004-03-08

ApplicantDrm Research Laboratories, Inc.
Decision Date2004-03-08
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ZTI IMPLANTS SYSTEM, DRM IMPLANTS is the device name listed in this FDA 510(k) record. The listed applicant is Drm Research Laboratories, Inc.. It received FDA 510(k) clearance on 2004-03-08 under 510(k) number K034067. 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 ZTI IMPLANTS SYSTEM, DRM IMPLANTS?

ZTI IMPLANTS SYSTEM, DRM IMPLANTS is a medical device that received FDA 510(k) clearance on 2004-03-08. The listed applicant is Drm Research Laboratories, Inc.. The 510(k) number is K034067.

When did ZTI IMPLANTS SYSTEM, DRM IMPLANTS receive FDA 510(k) clearance?

ZTI IMPLANTS SYSTEM, DRM IMPLANTS received FDA 510(k) clearance on 2004-03-08, under 510(k) number K034067.

Who is the listed applicant for ZTI IMPLANTS SYSTEM, DRM IMPLANTS?

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

What is the FDA product code for ZTI IMPLANTS SYSTEM, DRM IMPLANTS?

The FDA product code for ZTI IMPLANTS SYSTEM, DRM IMPLANTS is 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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