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FDA 510(k)

NAVITRACK SYSTEM-OPTICAL TKR CT-LESS, MODEL 900.120

K-Number: K021760 · 2002-08-27

ApplicantOrthosoft, Inc.
Decision Date2002-08-27
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

NAVITRACK SYSTEM-OPTICAL TKR CT-LESS, MODEL 900.120 is the device name listed in this FDA 510(k) record. The listed applicant is Orthosoft, Inc.. It received FDA 510(k) clearance on 2002-08-27 under 510(k) number K021760. 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 NAVITRACK SYSTEM-OPTICAL TKR CT-LESS, MODEL 900.120?

NAVITRACK SYSTEM-OPTICAL TKR CT-LESS, MODEL 900.120 is a medical device that received FDA 510(k) clearance on 2002-08-27. The listed applicant is Orthosoft, Inc.. The 510(k) number is K021760.

When did NAVITRACK SYSTEM-OPTICAL TKR CT-LESS, MODEL 900.120 receive FDA 510(k) clearance?

NAVITRACK SYSTEM-OPTICAL TKR CT-LESS, MODEL 900.120 received FDA 510(k) clearance on 2002-08-27, under 510(k) number K021760.

Who is the listed applicant for NAVITRACK SYSTEM-OPTICAL TKR CT-LESS, MODEL 900.120?

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 NAVITRACK SYSTEM-OPTICAL TKR CT-LESS, MODEL 900.120?

The FDA product code for NAVITRACK SYSTEM-OPTICAL TKR CT-LESS, MODEL 900.120 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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