510(k) Report

Devices descending from K091995

16 later devices reach Laguna Size 8 Pedicle Screw System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K103748Laguna Pedicle Screw SystemPhygen, LLC201115—
+2K122332Towerlox Pedicle Screw SystemCaptiva Spine201214—
+3K162576FORTEZZA Spinal Stabilization SystemOsso Surgical20160—
+3K152781Adena-Zina SystemShanghai Sanyou Medical Co, Ltd.20165—
+3K131538Caplox II Pedicle Screw System/Towerlox Pedicle Screw SystemCaptiva Spine20136—
+4K240392JAZZ Spinal SystemImplanet20241—
+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—
+4K180475CapLOX II® / TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc.20180—
+4K151116CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20153—
+5K252437JAZZ Spinal SystemImplanet20250—
+5K172105The Plateau-LO Spacer SystemLife Spine, Inc.20181—
+5K160020Captiva Spine and CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20160—
+6K182470Plateau Spacer SystemLife Spine20180—