510(k) Report

Devices descending from K100605

33 later devices reach Mis System through their predicates, nearest generation first.

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