{"product_id":"fda-510k-k022579-stryker-navigation-system-knee-module","title":"FDA 510(k) K022579, STRYKER NAVIGATION SYSTEM-KNEE MODULE, by Stryker Leibinger","description":"\u003cp\u003eFDA 510(k) records for \u003cstrong\u003eSTRYKER NAVIGATION SYSTEM-KNEE MODULE\u003c\/strong\u003e (K022579), submitted by Stryker Leibinger.\u003c\/p\u003e\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003e510(k) Number:\u003c\/strong\u003e K022579\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eDevice Classification:\u003c\/strong\u003e Neurological Stereotaxic Instrument\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eApplicant:\u003c\/strong\u003e Stryker Leibinger\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eDate Received:\u003c\/strong\u003e 08\/05\/2002\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eDecision Date:\u003c\/strong\u003e 06\/02\/2003\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eDecision:\u003c\/strong\u003e Substantially Equivalent (SESE)\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eRegulation Number:\u003c\/strong\u003e 882.456\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eProduct Code:\u003c\/strong\u003e HAW\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eRegulation Medical Specialty:\u003c\/strong\u003e Neurology\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eReview Panel:\u003c\/strong\u003e Neurology\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eTotal Pages:\u003c\/strong\u003e 636 (102 unredacted, 83% redacted overall)\u003c\/li\u003e\n\u003c\/ul\u003e\u003cp\u003e\u003cstrong\u003eWhat's in this document\u003c\/strong\u003e (sections may appear in any order):\u003c\/p\u003e\u003cul\u003e\n\u003cli\u003e~ \u003cstrong\u003e510(k) Summary \/ Statement:\u003c\/strong\u003e 55% redacted\u003c\/li\u003e\n\u003cli\u003e~ \u003cstrong\u003eIndications for Use:\u003c\/strong\u003e 55% redacted\u003c\/li\u003e\n\u003cli\u003e~ \u003cstrong\u003eDevice Description:\u003c\/strong\u003e 56% redacted\u003c\/li\u003e\n\u003cli\u003e~ \u003cstrong\u003eSubstantial Equivalence \/ Predicate:\u003c\/strong\u003e 53% redacted\u003c\/li\u003e\n\u003cli\u003e~ \u003cstrong\u003ePerformance \/ Bench Testing:\u003c\/strong\u003e 58% redacted\u003c\/li\u003e\n\u003cli\u003e✗ \u003cstrong\u003eBiocompatibility:\u003c\/strong\u003e 83% redacted\u003c\/li\u003e\n\u003cli\u003e— \u003cstrong\u003eSoftware \/ Cybersecurity:\u003c\/strong\u003e no distinct section found\u003c\/li\u003e\n\u003cli\u003e✗ \u003cstrong\u003eSterilization \/ Shelf Life:\u003c\/strong\u003e 81% redacted\u003c\/li\u003e\n\u003cli\u003e✗ \u003cstrong\u003eLabeling \/ IFU:\u003c\/strong\u003e 84% redacted\u003c\/li\u003e\n\u003cli\u003e✗ \u003cstrong\u003eClinical Data:\u003c\/strong\u003e 91% redacted\u003c\/li\u003e\n\u003cli\u003e✗ \u003cstrong\u003eFDA Correspondence:\u003c\/strong\u003e 100% redacted\u003c\/li\u003e\n\u003cli\u003e✓ \u003cstrong\u003eRisk Analysis \/ FMEA:\u003c\/strong\u003e 0% redacted\u003c\/li\u003e\n\u003cli\u003e✓ \u003cstrong\u003eElectromagnetic Compatibility (EMC):\u003c\/strong\u003e 0% redacted\u003c\/li\u003e\n\u003c\/ul\u003e\u003cp\u003e\u003cem\u003eSection contents and redaction percentages are AI-assisted estimates based on automated document analysis. Actual content may vary.\u003c\/em\u003e\u003c\/p\u003e","brand":"FDA","offers":[{"title":"Default Title","offer_id":51454813339812,"sku":"FDA510K022579","price":299.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0659\/0677\/0084\/files\/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400","url":"https:\/\/foiadocs.com\/products\/fda-510k-k022579-stryker-navigation-system-knee-module","provider":"FOIA Document Source","version":"1.0","type":"link"}