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FDA 510(k)

NAVITRACK SYSTEM-OS KNEE UNIVERSAL, MODEL PRO-05002

K-Number: K060336 · 2006-04-28

ApplicantOrthosoft, Inc.
Decision Date2006-04-28
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

NAVITRACK SYSTEM-OS KNEE UNIVERSAL, MODEL PRO-05002 is the device name listed in this FDA 510(k) record. The listed applicant is Orthosoft, Inc.. It received FDA 510(k) clearance on 2006-04-28 under 510(k) number K060336. 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-OS KNEE UNIVERSAL, MODEL PRO-05002?

NAVITRACK SYSTEM-OS KNEE UNIVERSAL, MODEL PRO-05002 is a medical device that received FDA 510(k) clearance on 2006-04-28. The listed applicant is Orthosoft, Inc.. The 510(k) number is K060336.

When did NAVITRACK SYSTEM-OS KNEE UNIVERSAL, MODEL PRO-05002 receive FDA 510(k) clearance?

NAVITRACK SYSTEM-OS KNEE UNIVERSAL, MODEL PRO-05002 received FDA 510(k) clearance on 2006-04-28, under 510(k) number K060336.

Who is the listed applicant for NAVITRACK SYSTEM-OS KNEE UNIVERSAL, MODEL PRO-05002?

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-OS KNEE UNIVERSAL, MODEL PRO-05002?

The FDA product code for NAVITRACK SYSTEM-OS KNEE UNIVERSAL, MODEL PRO-05002 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-06003K043536NAVITRACK SYSTEM - S&N IMAGE FREE KNEEK041369NAVITRACK SYSTEM - S&N IMAGE FREE HIP, MODEL PRO-03017

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Related Devices (Code: 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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