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FDA 510(k)

NAVITRACK SYSTEM - TOTAL HIP REPLACEMENT CT-FREE

K-Number: K032917 · 2003-10-21

ApplicantOrthosoft, Inc.
Decision Date2003-10-21
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

NAVITRACK SYSTEM - TOTAL HIP REPLACEMENT CT-FREE is the device name listed in this FDA 510(k) record. The listed applicant is Orthosoft, Inc.. It received FDA 510(k) clearance on 2003-10-21 under 510(k) number K032917. 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 - TOTAL HIP REPLACEMENT CT-FREE?

NAVITRACK SYSTEM - TOTAL HIP REPLACEMENT CT-FREE is a medical device that received FDA 510(k) clearance on 2003-10-21. The listed applicant is Orthosoft, Inc.. The 510(k) number is K032917.

When did NAVITRACK SYSTEM - TOTAL HIP REPLACEMENT CT-FREE receive FDA 510(k) clearance?

NAVITRACK SYSTEM - TOTAL HIP REPLACEMENT CT-FREE received FDA 510(k) clearance on 2003-10-21, under 510(k) number K032917.

Who is the listed applicant for NAVITRACK SYSTEM - TOTAL HIP REPLACEMENT CT-FREE?

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 - TOTAL HIP REPLACEMENT CT-FREE?

The FDA product code for NAVITRACK SYSTEM - TOTAL HIP REPLACEMENT CT-FREE is HAW.

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Other records listing Orthosoft, Inc. as applicant

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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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