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FDA 510(k)

NAVITRACK

K-Number: K981315 · 1998-07-09

ApplicantOrthosoft, Inc.
Decision Date1998-07-09
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

NAVITRACK is the device name listed in this FDA 510(k) record. The listed applicant is Orthosoft, Inc.. It received FDA 510(k) clearance on 1998-07-09 under 510(k) number K981315. 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?

NAVITRACK is a medical device that received FDA 510(k) clearance on 1998-07-09. The listed applicant is Orthosoft, Inc.. The 510(k) number is K981315.

When did NAVITRACK receive FDA 510(k) clearance?

NAVITRACK received FDA 510(k) clearance on 1998-07-09, under 510(k) number K981315.

Who is the listed applicant for NAVITRACK?

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?

The FDA product code for NAVITRACK is HAW.

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Other records listing Orthosoft, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K131409CAS PSI KNEE SYSTEMK100599CAS FIXATION PIN 3.2 DIA X 180 MM STR, CAS FIXATON PIN 3.2 DIA X 80 MM STR, CAS FIXATON PIN 3.2 DIA X 150 MMK071929NAVITRACK SYSTEM- PARTIAL HIP RESURFACING UNIVERSALK071714NAVITRACK SYSTEM - OS UNICONDYLAR KNEE UNIVERSAL, MODEL# PRO-06003K060336NAVITRACK SYSTEM-OS KNEE UNIVERSAL, MODEL PRO-05002K043536NAVITRACK SYSTEM - S&N IMAGE FREE KNEE

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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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