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FDA 510(k)

NAVITRACK SYSTEM - S&N IMAGE FREE KNEE

K-Number: K043536 · 2005-01-14

ApplicantOrthosoft, Inc.
Decision Date2005-01-14
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

NAVITRACK SYSTEM - S&N IMAGE FREE KNEE is the device name listed in this FDA 510(k) record. The listed applicant is Orthosoft, Inc.. It received FDA 510(k) clearance on 2005-01-14 under 510(k) number K043536. 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 - S&N IMAGE FREE KNEE?

NAVITRACK SYSTEM - S&N IMAGE FREE KNEE is a medical device that received FDA 510(k) clearance on 2005-01-14. The listed applicant is Orthosoft, Inc.. The 510(k) number is K043536.

When did NAVITRACK SYSTEM - S&N IMAGE FREE KNEE receive FDA 510(k) clearance?

NAVITRACK SYSTEM - S&N IMAGE FREE KNEE received FDA 510(k) clearance on 2005-01-14, under 510(k) number K043536.

Who is the listed applicant for NAVITRACK SYSTEM - S&N IMAGE FREE KNEE?

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 - S&N IMAGE FREE KNEE?

The FDA product code for NAVITRACK SYSTEM - S&N IMAGE FREE KNEE 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-05002K041369NAVITRACK SYSTEM - S&N IMAGE FREE HIP, MODEL PRO-03017

View all 14 devices →

Related Devices (Code: HAW)

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.

K253856Geniant Cranial (Navigated Neurosurgical Positioning Robot)Koh Young Technology, Inc.K261932Leksell® Vantage Stereotactic SystemElekta Solutions ABK253663Zeta Navigation SystemZeta Surgical, Inc.K253379Stealth AXiS Cranial clinical applicationMedtronic Navigation, Inc.K231897NeuroAlign softwareMedivis, Inc.K251317SOLOPASS 2.0 SystemIntravent Medical Partners

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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