510(k) Report

Devices descending from K081228

39 later devices reach Capsure PS (R) Spine System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K162760Spine Wave Anterior Cervical Spine SystemSpine Wave, Inc.20171—
+1K120646Capsure (R) PS SystemSpine Wave, Inc.20120—
+1K111913Capsure (R) PS SystemSpine Wave, Inc.20111—
+1K100605Mis SystemSpine Wave, Inc.201033—
+1K083353Capsure (R) PS SystemSpine Wave, Inc.200836—
+2K173175Paramount Anterior Cervical Cage SystemSpine Wave, Inc.20170—
+2K151813Sniper Spine SystemSpine Wave, Inc.20159—
+2K123164Spinefrontier Pedfuse Pedicle Screw SystemSpinefrontier, Inc.201336
+2K111115Captiva Spine Caplox II Spinal Fixation SystemCaptiva Spine, Inc.201116—
+2K100122Modification to Capsure PS SystemSpine Wave, Inc.20102—
+2K083743Capsure PS SystemSpine Wave, Inc.20093—
+3K191655MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd.20200—
+3K152174Sniper Spine SystemSpine Wave, Inc.20158—
+3K143377PedFuse Pedicle Screw SystemSpinefrontier, Inc.20150—
+3K133153Spinefrontier Pedfuse Pedicle Screw SystemSpinefrontier, Inc.20141—
+3K122332Towerlox Pedicle Screw SystemCaptiva Spine201214—
+3K120292Caplox II Pedicle Screw SystemCaptiva Spine, Inc.2012151
+4K162576FORTEZZA Spinal Stabilization SystemOsso Surgical20160—
+4K160003Sniper (R) Spine SystemSpine Wave, Inc.20167—
+4K152781Adena-Zina SystemShanghai Sanyou Medical Co, Ltd.20165—
+4K131538Caplox II Pedicle Screw System/Towerlox Pedicle Screw SystemCaptiva Spine20136—
+5K240392JAZZ Spinal SystemImplanet20241—
+5K240685Salvo® Spine SystemSpine Wave, Inc.20242—
+5K230961Zeus Spinal SystemShanghai Sanyou Medical Co, Ltd.20232—
+5K231931Adena-Zina Spinal SystemShanghai Sanyou Medical Co, Ltd.20230—
+5K212066Adena-Zina SystemShanghai Sanyou Medical Co, Ltd.20213—
+5K193270CapLOX II®/TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc.20200—
+5K182954Salvo™ Spine SystemSpine Wave, Inc.20186—
+5K180475CapLOX II® / TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc.20180—
+5K151116CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20153—
+6K260286Dynamo™ Spinal Cement; Salvo® Spine SystemSpine Wave, Inc.20260—
+6K252437JAZZ Spinal SystemImplanet20250—
+6K251131Annex® 2 Adjacent Level SystemSpine Wave, Inc.20250—
+6K191045Salvo™ Spine SystemSpine Wave, Inc.20195—
+6K172105The Plateau-LO Spacer SystemLife Spine, Inc.20181—
+6K160020Captiva Spine and CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20160—
+7K202476Salvo® Spine SystemSpine Wave, Inc.20204—
+7K182470Plateau Spacer SystemLife Spine20180—
+8K222362Salvo® Spine SystemSpine Wave, Inc.20223—