{"product_id":"fda-510k-k181420","title":"FDA 510(k) K181420, Aequalis Flex Revive Shoulder System, by Tornier, Inc.","description":"\u003cp\u003e\n\u003cstrong\u003eDevice Classification Name: \u003c\/strong\u003eProsthesis, Shoulder, Semi-Constrained, Metal\/Polymer Cemented\u003cbr\u003e\n\u003cstrong\u003e510(k) Number: \u003c\/strong\u003eK181420\u003cbr\u003e\n\u003cstrong\u003eDevice Name:\u003c\/strong\u003e Aequalis Flex Revive Shoulder System\u003cbr\u003e\n\u003cstrong\u003eApplicant:\u003c\/strong\u003e Tornier, Inc.\u003cbr\u003e\n\u003cstrong\u003eRegulation Number: \u003c\/strong\u003e888.366\u003cbr\u003e\n\u003cstrong\u003eClassification Product Code: \u003c\/strong\u003eKWS\u003cbr\u003e\n\u003cstrong\u003eDate Received: \u003c\/strong\u003e2018-05-31\u003cbr\u003e\n\u003cstrong\u003eDecision Date:\u003c\/strong\u003e 2018-09-20\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 1,210\u003cbr\u003e\n\u003cstrong\u003eFully redacted pages:\u003c\/strong\u003e 892\u003cbr\u003e\n\u003cstrong\u003eContent pages:\u003c\/strong\u003e 318\n\u003c\/p\u003e","brand":"FDA","offers":[{"title":"Default Title","offer_id":51309544964260,"sku":"FDA510K181420","price":923.95,"currency_code":"USD","in_stock":true}],"url":"https:\/\/foiadocs.com\/products\/fda-510k-k181420","provider":"FOIA Document Source","version":"1.0","type":"link"}