510(k) Report

Devices descending from K051216

29 later devices reach Hydralok System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K102870Exactech Proliant Polyaxial Pedicle Screw SystemExactech, Inc.20119—
+1K100956Spondy Spinal Fixation SystemAllure Spine LLC201017—
+1K051044Arctec Semirigid Plating SystemAltiva Corp.20050—
+2K170821ChoiceSpine™ Proliant® Posterior Pedicle Screw and Hook Fixation SystemChoicespine, LP20170—
+2K151704Diplomat® Spinal SystemSignus Medizintechnik GmbH20164—
+2K143230Palladian Lumbar Pedicle Screw SystemNeurostructures, Inc.20150—
+2K141282PGS 5.5 MM Cannulated Pedicle ScrewPinnacle Spine Group20141—
+2K111115Captiva Spine Caplox II Spinal Fixation SystemCaptiva Spine, Inc.201116—
+3K243281LOCK-IN Spinal Fixation SystemLock-In USA Corp20240—
+3K191655MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd.20200—
+3K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+3K122332Towerlox Pedicle Screw SystemCaptiva Spine201214—
+3K120292Caplox II Pedicle Screw SystemCaptiva Spine, Inc.2012151
+4K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+4K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+4K162576FORTEZZA Spinal Stabilization SystemOsso Surgical20160—
+4K152781Adena-Zina SystemShanghai Sanyou Medical Co, Ltd.20165—
+4K131538Caplox II Pedicle Screw System/Towerlox Pedicle Screw SystemCaptiva Spine20136—
+5K240392JAZZ Spinal SystemImplanet20241—
+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—
+5K180475CapLOX II® / TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc.20180—
+5K151116CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20153—
+6K252437JAZZ Spinal SystemImplanet20250—
+6K172105The Plateau-LO Spacer SystemLife Spine, Inc.20181—
+6K160020Captiva Spine and CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20160—
+7K182470Plateau Spacer SystemLife Spine20180—