{"product_id":"fda-510k-k192930","title":"FDA 510(k) K192930, Dymaxeon Spine System, by Back 2 Basics Direct, LLC","description":"\u003cp\u003e\n\u003cstrong\u003eDevice Classification Name: \u003c\/strong\u003eThoracolumbosacral Pedicle Screw System\u003cbr\u003e\n\u003cstrong\u003e510(k) Number: \u003c\/strong\u003eK192930\u003cbr\u003e\n\u003cstrong\u003eDevice Name:\u003c\/strong\u003e Dymaxeon Spine System\u003cbr\u003e\n\u003cstrong\u003eApplicant:\u003c\/strong\u003e Back 2 Basics Direct, LLC\u003cbr\u003e\n\u003cstrong\u003eRegulation Number: \u003c\/strong\u003e888.307\u003cbr\u003e\n\u003cstrong\u003eClassification Product Code: \u003c\/strong\u003eNKB\u003cbr\u003e\n\u003cstrong\u003eDate Received: \u003c\/strong\u003e2019-10-17\u003cbr\u003e\n\u003cstrong\u003eDecision Date:\u003c\/strong\u003e 2020-05-12\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 471\u003cbr\u003e\n\u003cstrong\u003eFully redacted pages:\u003c\/strong\u003e 325\u003cbr\u003e\n\u003cstrong\u003eContent pages:\u003c\/strong\u003e 146\n\u003c\/p\u003e","brand":"FDA","offers":[{"title":"Default Title","offer_id":51309545128100,"sku":"FDA510K192930","price":509.85,"currency_code":"USD","in_stock":true}],"url":"https:\/\/foiadocs.com\/products\/fda-510k-k192930","provider":"FOIA Document Source","version":"1.0","type":"link"}