{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-04-13", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "third_party_flag": "N", "city": "Dallas", "advisory_committee_description": "Orthopedic", "address_1": "2300 N. Haskell Ave.", "address_2": "", "statement_or_summary": "Summary", "product_code": "OVD", "openfda": { "registration_number": [ "3005706667", "3010531069", "3004499989", "1221763", "1000200989", "3009962553", "3007289746", "2133928", "3010863450", "3003477135", "3010560653", "3012131184", "3003120897", "3004719693", "1834331", "3013194153", "3012764194", "3003525643", "2647346", "3003637761", "3010123206", "2183744", "2530808", "3010178296", "2028632", "3014725904", "3017528621", "1649518", "1649379", "9681465", "3006694268", "3010162973", "1030489", "3004635447", "3016237080", "3015941638", "3019767615", "3005819474", "9611813", "3010593798", "3015876273", "2648623", "3011577940", "2032098", "2027467", "3010120135", "3009888740", "3012120772", "3022295665", "1834379", "3009049161", "3007993775", "3010041499", "3010531060", "3009973505", "2027062", "3014252644", "3007728266", "3000170817", "3004638600", "3010370554", "3010120148", "1319660", "3003597504", "3009417901", "3010326971", "1824199", "3004024955", "3011187779", "3005061536", "9617544", "2134285", "9610612", "3015398319", "3004788213", "1047843", "1526711", "3006639944", "3009882675", "3010866843", "3009241418", "3009380063", "3010462278", "3009973699", "3005178931", "3016112537", "1420032", "2532027", "3010047402", "1835296", "3015216945", "3010197224", "9611390", "3010047454", "3018210489", "3013820501", "3009149199", "3013055499", "3008110533", "3010041430", "3009756327", "1530390", "3005031160", "3009144915", "3010097171", "1833986", "3009973336", "3010363503", "3010009693", "3008773560", "3016084569", "3014273501", "3003387384", "3017597868", "3006128100", "3012028003", "3006017180", "1000517406", "3006783837", "1835444", "3015151147", "3019837678", "3004889950", "3043543260", "3025603301", "3015869492", "3033509898", "3008992889", "3004153896", "3026776", "2183946", "3008114965", "2032521", "3010120104", "3003639920", "1835251", "1424263", "3002807561", "3010160527", "8020776", "3009504230", "3010197239", "1526534", "3011127597", "9616680", "3036756245", "3013422236", "3016443334", "3007303113", "3013491327", "3008262872", "3030412764", "3003761012", "3010705004", "3004188066", "1828464", "3009887475", "8043792", "3017048829", "3039167712", "3013462427", "1423662", "3008868758", "3007922509", "3009959868", "3008850074", "3008864603", "3009882462", "3013422238", "3014655115", "2531195", "3006272282", "3012447612", "3006846753", "3010386387", "1057425", "3023852420", "2531477", "3005739886", "3018094310", "3017936978", "2031966", "3019878714", "3015212339", "3006791286", "3016460869", "3006563559", "3004112448", "3012711663", "1833920", "3014680795", "1526439", "3005596514", "3008583793", "3003935342", "3015399803", "3005180920", "1000432246", "1928237", "3010032903", "3012428435", "3005677016", "1226544", "3009998573", "1720929", "3010057495", "3016668776", "1220477", "3010370500", "3010049501", "3000270450", "3009189869", "3015869493", "3013413393", "1924669", "2135156", "3004142400", "3016438694", "3003898943", "1424434", "3008812560", "3031081659", "3005497913", "1935627", "1827096", "3005641619", "3006982954", "3010663372", "2032093", "3009051471", "2029275", "3017565094", "3003435550", "2134470", "1724955", "9611579", "1527105", "3011795235", "1450662", "3004774118", "3015882686", "9615766", "3005144609", "3020307303", "3004893332", "3037407500", "3006404071", "3016050940", "2183449", "1529009", "3011390763", "3013758617", "3007766698", "3014967969" ], "fei_number": [ "3005706667", "3010531069", "3004499989", "1221763", "3009322142", "1000200989", "3009962553", "3007289746", "1000135253", "3010863450", "3003477135", "3002807041", "3010560653", "3012131184", "3003120897", "3004719693", "2647346", "3013194153", "3012764194", "3003525643", "1000136478", "3003637761", "3010123206", "2183744", "3001642380", "3014725904", "3017528621", "3006694268", "3004635447", "3016237080", "3019767615", "3005819474", "3002980729", "3010593798", "3015876273", "3003142829", "3002807040", "3011577940", "2027467", "3010120135", "3009888740", "3012120772", "2648623", "3022295665", "3009049161", "3000717902", "3007993775", "3010531060", "1000221916", "3009973505", "2027062", "3014252644", "3002904345", "3007728266", "3000170817", "3004638600", "3010370554", "3010120148", "3000215273", "3003597504", "3009417901", "3010326971", "3003128516", "1824199", "3004024955", "3011187779", "3005061536", "3004788213", "3008647423", "3000207350", "1047843", "1526711", "1000125025", "3002806315", "3006639944", "3003690049", "3010866843", "3009241418", "3009380063", "3010462278", "3009973699", "3005178931", "3016112537", "1420032", "3010047402", "3002807038", "3002806773", "3015216945", "3010197224", "3010047454", "3018210489", "3013820501", "3009149199", "3013055499", "4224", "3008110533", "3010041430", "3002287318", "3000718490", "3005031160", "3009144915", "3010097171", "3000215103", "3009973336", "3010363503", "3010009693", "1000149660", "3008773560", "3002795782", "3016084569", "3014273501", "1000306303", "1000116116", "3003387384", "3002808269", "3017597868", "3006128100", "3012028003", "1000477302", "3006017180", "1000517406", "3015151147", "3019837678", "3043543260", "3004889950", "3025603301", "3015869492", "3033509898", "3008992889", "3002807113", "3004153896", "3008114965", "3010120104", "3003639920", "3002807561", "3009504230", "3036756245", "3010197239", "1526534", "3011127597", "3003058119", "3003179719", "3013422236", "3016443334", "3007303113", "3013491327", "3008262872", "3030412764", "3003761012", "1000522098", "3010705004", "3004188066", "1828464", "3009887475", "3017048829", "3039167712", "3013462427", "3002806685", "3008868758", "3007922509", "3009959868", "3008850074", "3001236277", "3009882462", "3008864603", "3013422238", "1000306431", "3014655115", "3002462840", "3003015552", "3000210784", "3006272282", "3012447612", "3006846753", "3010386387", "3023852420", "3005739886", "3018094310", "3017936978", "3019878714", "3003292403", "3015212339", "3006791286", "3003574398", "3016460869", "3006563559", "3007932279", "3004112448", "3012711663", "3014680795", "1526439", "3005596514", "3008583793", "3003935342", "3015399803", "3005180920", "1000432246", "1928237", "3010032903", "3012428435", "3005677016", "3009998573", "1720929", "3008599177", "3010057495", "3016668776", "3003110073", "3010370500", "3010049501", "3000205591", "3009189869", "3000270450", "3015869493", "3013413393", "1220477", "1924669", "3003112432", "3004142400", "3016438694", "3003898943", "3008812560", "1000139987", "3031081659", "3005497913", "1935627", "1827096", "1000115656", "3000717687", "3010663372", "3005641619", "3006982954", "1000306340", "3009051471", "3017565094", "3003435550", "1000069183", "3011795235", "1450662", "3015882686", "3005144609", "3020307303", "3004893332", "3037407500", "3006404071", "3016050940", "2183449", "3009256700", "3011764740", "3011390763", "3013758617", "3002459190", "3007766698", "3003058448", "3014967969" ], "device_name": "Intervertebral Fusion Device With Integrated Fixation, Lumbar", "medical_specialty_description": "Orthopedic", "regulation_number": "888.3080", "device_class": "2" }, "zip_code": "75204", "applicant": "Evolution Spine", "decision_date": "2023-02-07", "decision_code": "SESE", "country_code": "US", "device_name": "EVOLUTION SPINE Interbody System", "advisory_committee": "OR", "contact": "Todd Wallenstein", "expedited_review_flag": "", "k_number": "K223146", "state": "TX", "date_received": "2022-10-05", "review_advisory_committee": "OR", "postal_code": "75204", "decision_description": "Substantially Equivalent", "clearance_type": "Traditional" } ] }