{"product_id":"fda-510k-k161210-rialto-si-fusion-system-with-ipc-powerease-and-stealthstation-instruments","title":"FDA 510(k) K161210, Rialto SI Fusion System with IPC Powerease and StealthStation Instruments, by Medtronic Sofamor Danek","description":"\u003cp\u003e\u003cb\u003e510(K) Number:\u003c\/b\u003e K161210 \u003cbr\u003e\u003cb\u003eDevice Name:\u003c\/b\u003e RIALTO(TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC(TM) Powerease(TM) System, and Medtronic Navigated Manual Reusable Instruments for use with the StealthStation(TM) and IPC(TM) Powerease(TM) Systems \u003cbr\u003e\u003cb\u003eManufacturer:\u003c\/b\u003e Medtronic Sofamor Danek\u003cbr\u003e\u003cb\u003eDevice Classification Name:\u003c\/b\u003e sacroiliac joint fixation \u003cbr\u003e\u003cb\u003eRegulation Number:\u003c\/b\u003e 888.3040 \u003cbr\u003e\u003cb\u003eClassification Product Code:\u003c\/b\u003e OUR \u003cbr\u003e\u003cb\u003eDate Received:\u003c\/b\u003e 04\/28\/2016 \u003cbr\u003e\u003cb\u003eDecision Date:\u003c\/b\u003e 08\/12\/2016 \u003cbr\u003e\u003cb\u003eRegulation Medical Specialty:\u003c\/b\u003e Orthopedic\u003c\/p\u003e\n\u003cp\u003e\u003cmeta charset=\"utf-8\"\u003eTotal pages: 340\u003cbr data-start=\"16\" data-end=\"19\"\u003eFully redacted pages: 319\u003cbr data-start=\"44\" data-end=\"47\"\u003eContent pages: 21\u003c\/p\u003e","brand":"FDA","offers":[{"title":"Default Title","offer_id":51429484789924,"sku":"FDA510K161210","price":116.94,"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-k161210-rialto-si-fusion-system-with-ipc-powerease-and-stealthstation-instruments","provider":"FOIA Document Source","version":"1.0","type":"link"}