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FDA 510(k)

TRAXYLOC-1 SYSTEM

K-Number: K050663 · 2005-04-08

ApplicantTraxyz Medical, Inc.
Decision Date2005-04-08
Product CodeIZH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

TRAXYLOC-1 SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Traxyz Medical, Inc.. It received FDA 510(k) clearance on 2005-04-08 under 510(k) number K050663. The device is classified under product code IZH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRAXYLOC-1 SYSTEM?

TRAXYLOC-1 SYSTEM is a medical device that received FDA 510(k) clearance on 2005-04-08. The listed applicant is Traxyz Medical, Inc.. The 510(k) number is K050663.

When did TRAXYLOC-1 SYSTEM receive FDA 510(k) clearance?

TRAXYLOC-1 SYSTEM received FDA 510(k) clearance on 2005-04-08, under 510(k) number K050663.

Who is the listed applicant for TRAXYLOC-1 SYSTEM?

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

What is the FDA product code for TRAXYLOC-1 SYSTEM?

The FDA product code for TRAXYLOC-1 SYSTEM is IZH.

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Related Devices (Code: IZH)

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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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