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Recognized a 510(k)/PMA number — showing its clearance record and devices.

Clearance record K211769

OneLIF Intervertebral Body Replacement System · Novapproach Spine · decided 2021-09-07 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
OneLIF™013-331-1222Novapproach Spine LLCMAX OVDG07001333112220
OneLIF™011-213-1610Novapproach Spine LLCMAX OVDG07001121316100
OneLIF™015-050-0000Novapproach Spine LLCMAX OVDG07001505000000
OneLIF™013-310-1000Novapproach Spine LLCMAX OVDG07001331010000
OneLIF™010-325-2209Novapproach Spine LLCMAX OVDG07001032522090
OneLIF™011-107-1411Novapproach Spine LLCMAX OVDG07001110714110
OneLIF™013-211-1220Novapproach Spine LLCMAX OVDG07001321112200
OneLIF™013-210-1000Novapproach Spine LLCMAX OVDG07001321010000
OneLIF™014-100-0000Novapproach Spine LLCMAX OVDG07001410000000
OneLIF™012-001-4516Novapproach Spine LLCMAX OVDG07001200145160
OneLIF™010-125-1808Novapproach Spine LLCMAX OVDG07001012518080
OneLIF™010-113-1006-2Novapproach Spine LLCMAX OVDG070010113100620
OneLIF™013-111-1218Novapproach Spine LLCMAX OVDG07001311112180
OneLIF™013-311-1000Novapproach Spine LLCMAX OVDG07001331110000
OneLIF™013-200-1000Novapproach Spine LLCMAX OVDG07001320010000
OneLIF™011-613-0002Novapproach Spine LLCMAX OVDG07001161300020
OneLIF™010-219-1810Novapproach Spine LLCMAX OVDG07001021918100
OneLIF™012-003-4028Novapproach Spine LLCMAX OVDG07001200340280
OneLIF™010-113-1410Novapproach Spine LLCMAX OVDG07001011314100
OneLIF™013-200-1220Novapproach Spine LLCMAX OVDG07001320012200
OneLIF™010-213-1812Novapproach Spine LLCMAX OVDG07001021318120
OneLIF™011-713-0004Novapproach Spine LLCMAX OVDG07001171300040
OneLIF™010-307-1612Novapproach Spine LLCMAX OVDG07001030716120
OneLIF™013-130-1218Novapproach Spine LLCMAX OVDG07001313012180
OneLIF™012-001-4524Novapproach Spine LLCMAX OVDG07001200145240