{"product_id":"fda-510k-k243838","title":"FDA 510(k) K243838, NEXXT MATRIXX® SI System, by Nexxt Spine","description":"\u003cp\u003e\n\u003cstrong\u003eDevice Classification Name: \u003c\/strong\u003eSacroiliac Joint Fixation\u003cbr\u003e\n\u003cstrong\u003e510(k) Number: \u003c\/strong\u003eK243838\u003cbr\u003e\n\u003cstrong\u003eDevice Name:\u003c\/strong\u003e NEXXT MATRIXX® SI System\u003cbr\u003e\n\u003cstrong\u003eApplicant:\u003c\/strong\u003e Nexxt Spine\u003cbr\u003e\n\u003cstrong\u003eRegulation Number: \u003c\/strong\u003e888.3040\u003cbr\u003e\n\u003cstrong\u003eClassification Product Code: \u003c\/strong\u003eOUR\u003cbr\u003e\n\u003cstrong\u003eDate Received: \u003c\/strong\u003e12\/13\/2024\u003cbr\u003e\n\u003cstrong\u003eDecision Date:\u003c\/strong\u003e 03\/14\/2025\u003cbr\u003e\n\u003cstrong\u003eDecision:\u003c\/strong\u003e Substantially Equivalent (SESE)\u003cbr\u003e\n\u003cstrong\u003eRegulation Medical Specialty: \u003c\/strong\u003eOrthopedic\u003cbr\u003e\n\u003cstrong\u003e510k Review Panel: \u003c\/strong\u003eOrthopedic\u003cbr\u003e\n\u003c\/p\u003e\n\u003cp\u003e\n\u003cstrong\u003eTotal number of pages:\u003c\/strong\u003e 523\u003cbr\u003e\n\u003cstrong\u003eFully redacted pages:\u003c\/strong\u003e 355\u003cbr\u003e\n\u003cstrong\u003eContent pages:\u003c\/strong\u003e 168\n\u003c\/p\u003e","brand":"FDA","offers":[{"title":"Default Title","offer_id":51313337893028,"sku":"FDA510K243838","price":607.5,"currency_code":"USD","in_stock":true}],"url":"https:\/\/foiadocs.com\/products\/fda-510k-k243838","provider":"FOIA Document Source","version":"1.0","type":"link"}