510(k) Report

Devices descending from K032394

230 later devices reach Stryker Spine Oasys System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K161369EVEREST Spinal SystemK2m, Incorporated20169—
+7K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+7K153031RANGE/DENALI/MESA Spinal SystemK2m, Incorporated20152—
+7K151216Everest Spinal SystemK2m, Inc.201511—
+7K150325Range/Denali/Mesa Spinal SystemK2m, Inc.201512—
+7K133402K2M Modular HooksK2m, Inc.20140—
+8K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+8K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+8K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+8K232318VICTORY™ Lumbar Plate SystemGlobus Medical, Inc.20230—
+8K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+8K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+8K231839CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate SystemL&K BIOMED Co., Ltd.20232—
+8K231841PathLoc SI Joint Fusion SystemL&K BIOMED Co., Ltd.20231—
+8K223521ZESPIN SI Joint Fusion SystemAegis Spine, Inc.20232—
+8K223719Paeon Anterior Cervical Plate System, Elatus Lumbar Plate SystemAegis Spine, Inc.20233—
+8K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+8K181188EVEREST Spinal SystemK2m, Inc.20186—
+8K171321K2M Navigation InstrumentsK2m201711
+8K153525Seneka II Polyscrew Pedicle Fixation SystemSenecka Spine20160—
+9K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.20260—
+9K251940PathLoc Lumbar Plate SystemL&K BIOMED Co., Ltd.20260—
+9K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+9K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+9K240201PathLoc SI Joint Fusion SystemL&K BIOMED Co., Ltd.20240—
+9K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+9K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—
+10K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+10K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+10K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—