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FDA 510(k)

NAVITRAK SYSTEM-OPTICAL OPTION, MODEL 900.004

K-Number: K002053 · 2000-08-03

ApplicantOrthosoft, Inc.
Decision Date2000-08-03
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

NAVITRAK SYSTEM-OPTICAL OPTION, MODEL 900.004 is the device name listed in this FDA 510(k) record. The listed applicant is Orthosoft, Inc.. It received FDA 510(k) clearance on 2000-08-03 under 510(k) number K002053. The device is classified under product code HAW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NAVITRAK SYSTEM-OPTICAL OPTION, MODEL 900.004?

NAVITRAK SYSTEM-OPTICAL OPTION, MODEL 900.004 is a medical device that received FDA 510(k) clearance on 2000-08-03. The listed applicant is Orthosoft, Inc.. The 510(k) number is K002053.

When did NAVITRAK SYSTEM-OPTICAL OPTION, MODEL 900.004 receive FDA 510(k) clearance?

NAVITRAK SYSTEM-OPTICAL OPTION, MODEL 900.004 received FDA 510(k) clearance on 2000-08-03, under 510(k) number K002053.

Who is the listed applicant for NAVITRAK SYSTEM-OPTICAL OPTION, MODEL 900.004?

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

What is the FDA product code for NAVITRAK SYSTEM-OPTICAL OPTION, MODEL 900.004?

The FDA product code for NAVITRAK SYSTEM-OPTICAL OPTION, MODEL 900.004 is HAW.

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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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