510(k) Report

Devices descending from K081636

542 later devices reach Peek-Optima Alif Spacer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+10K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+10K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+10K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+10K240625CORUS Navigation Access SystemProvidence Medical Technology, Inc.20244—
+10K232822Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system), Anterior…Gbs Commonwealth Co., Ltd.20232—
+10K231275Exceed™ Biplanar Expandable Interbody SystemSpine Wave, Inc.20232—
+10K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+10K223412LumiVy™ Lumbar IBF SystemVy Spine, LLC20235—
+10K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+10K221719ABTross ALIF Expandable Cage SystemAegis Spine, Inc.20222—
+10K210574NuVasive Pulse SystemNu Vasive, Incorporated202121
+10K201755WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody SystemSeaSpine Orthopedics Corporation202017—
+10K200613Tritanium® X TL Expandable Curved Posterior Lumbar CageStryker Corporation20205—
+10K193418SeaSpine Skipjack SystemSeaSpine Orthopedics Corporation20204—
+10K192132SeaSpine Beachside SystemSeaSpine Orthopedics Corporation2019591
+10K191621ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer…Choice Spine, LLC20194—
+11K261159Exceed® Biplanar Expandable Interbody SystemSpine Wave, Inc.20260—
+11K260329Ion-C Navigation InstrumentsSurGenTec, LLC20261—
+11K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+11K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+11K243816Testa TP Pivoting Spacer SystemSpine Wave, Inc.20250—
+11K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+11K243659FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion InstrumentsSeaSpine Orthopedics Corporation20250—
+11K233839Peridot-PT Anterior Cervical Intervertebral body fusion System; Peridot-PT…Gbs Commonwealth Co., Ltd.20231—
+11K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+11K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+11K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+11K230989Rod Registration FrameNu Vasive, Incorporated20230—
+11K223474PathLoc-TA Expandable Lumbar Cage SystemL&K BIOMED Co., Ltd.20231—
+11K213420WaveForm L System, WaveForm TO System, WaveForm TA SystemSeaSpine Orthopedics Corporation202211—
+11K212540Explorer TO SystemSeaSpine Orthopedics Corporation20213—
+11K203311ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20213—
+11K193636SeaSpine Reef TH SystemSeaSpine Orthopedics Corporation202056—
+12K262121Ion-L Navigated InstrumentsSurGenTec, LLC20260—
+12K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+12K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+12K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+12K242829BluEX Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20240—
+12K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+12K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+12K223869ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20232—