{"product_id":"fda-510k-k210497-seaspine-spacer-interbody-and-fusion-systems-multiple-models","title":"FDA 510(k) K210497, SeaSpine Spacer, Interbody and Fusion Systems (Multiple Models), by SeaSpine Orthopedics Corporation","description":"\u003cp\u003e\u003cstrong\u003eDevice Classification Name \u003c\/strong\u003e   Intervertebral Fusion Device With Bone Graft, Lumbar\u003cbr\u003e\u003cstrong\u003e510(k) Number  \u003c\/strong\u003e  K210497\u003cbr\u003e\u003cstrong\u003eDevice Name \u003c\/strong\u003e   SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu a•POD-L NanoMetalene, SeaSpine Vu e•POD System, SeaSpine Vu a•POD Prime NanoMetalene Intervertebral, SeaSpine Shoreline ACS - Anterior Cervical Standalone, SeaSpine Cervical Interbody RT System, SeaSpine Cambria System, SeaSpine Regatta Lateral System, SeaSpine Reef TO\/TA System, SeaSpine Reef TH System, SeaSpine Meridian System\u003cbr\u003e\u003cstrong\u003eApplicant \u003c\/strong\u003e   SeaSpine Orthopedics Corporation\u003cbr\u003e\u003cstrong\u003eRegulation Number \u003c\/strong\u003e   888.3080\u003cbr\u003e\u003cstrong\u003eClassification Product Code \u003c\/strong\u003e   MAX  \u003cbr\u003e\u003cstrong\u003eSubsequent Product Codes \u003c\/strong\u003e   MQP      ODP      OVD      OVE  \u003cbr\u003e\u003cstrong\u003eDate Received \u003c\/strong\u003e   02\/22\/2021\u003cbr\u003e\u003cstrong\u003eDecision Date\u003c\/strong\u003e    07\/07\/2021\u003cbr\u003e\u003cstrong\u003eDecision \u003c\/strong\u003e   Substantially Equivalent (SESE)\u003cbr\u003e\u003cstrong\u003eRegulation Medical Specialty  \u003c\/strong\u003e  Orthopedic\u003c\/p\u003e\n\u003cp\u003eTotal pages: 498  \u003cbr\u003eFully redacted pages: 259  \u003cbr\u003eContent pages: 239  \u003c\/p\u003e","brand":"FDA","offers":[{"title":"Default Title","offer_id":51429457854628,"sku":"FDA510K210497","price":586.93,"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-k210497-seaspine-spacer-interbody-and-fusion-systems-multiple-models","provider":"FOIA Document Source","version":"1.0","type":"link"}