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Stryker Navigation System - Hip Module

FDA 510(k)

Class II (US FDA 510(k))

510(k) K022365

by Stryker Instruments

Identifiers

510(k) Number
K022365 FDA 510(k)
FDA Product Code
HAW FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 882.4560 FDA 510(k)
Regulation Number
882.4560 FDA 510(k)
Advisory Committee
Neurology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Stryker Navigation System - Hip Module by Stryker Instruments — Class II — FDA_510K — listed in FDA 510(k) — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Stryker Instruments

Sources (1)

  • FDA 510(k) K022365 24 fields · synced Jun 18, 2026