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FDA 510(k)

STRYKER NAVIGATION SYSTEM-KNEE MODULE

K-Number: K022579 · 2003-06-02

ApplicantStryker Leibinger
Decision Date2003-06-02
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

STRYKER NAVIGATION SYSTEM-KNEE MODULE is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Leibinger. It received FDA 510(k) clearance on 2003-06-02 under 510(k) number K022579. 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 STRYKER NAVIGATION SYSTEM-KNEE MODULE?

STRYKER NAVIGATION SYSTEM-KNEE MODULE is a medical device that received FDA 510(k) clearance on 2003-06-02. The listed applicant is Stryker Leibinger. The 510(k) number is K022579.

When did STRYKER NAVIGATION SYSTEM-KNEE MODULE receive FDA 510(k) clearance?

STRYKER NAVIGATION SYSTEM-KNEE MODULE received FDA 510(k) clearance on 2003-06-02, under 510(k) number K022579.

Who is the listed applicant for STRYKER NAVIGATION SYSTEM-KNEE MODULE?

The FDA 510(k) record lists Stryker Leibinger as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STRYKER NAVIGATION SYSTEM-KNEE MODULE?

The FDA product code for STRYKER NAVIGATION SYSTEM-KNEE MODULE is HAW.

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Other records listing Stryker Leibinger 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.

K052871STRYKER CUSTOM TI IMPLANTK043250STRYKER PATIENT SPECIFIC POLYMER IMPLANTK041651STRYKER LEIBINGER SKELETAL ANCHORING SYSTEMK040022STRYKER LEIBINGER UNIVERSAL DISTAL RADIUS SYSTEMK023449NON-INVASIVE PATIENT FIXATION SYSTEMK013775TWINFIX INTERFRAGMENTARY COMPRESSION SCREW SYSTEM

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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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