510(k) Report

Devices descending from K082406

527 later devices reach Expandable Peek-Optima Implant through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+10K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+10K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+10K243816Testa TP Pivoting Spacer SystemSpine Wave, Inc.20250—
+10K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+10K243659FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion InstrumentsSeaSpine Orthopedics Corporation20250—
+10K241467Stable-C Interbody SystemNexus Spine, LLC20242—
+10K240416Tranquil-C Interbody SystemNexus Spine, LLC20243—
+10K233839Peridot-PT Anterior Cervical Intervertebral body fusion System; Peridot-PT…Gbs Commonwealth Co., Ltd.20231—
+10K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+10K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+10K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+10K230989Rod Registration FrameNu Vasive, Incorporated20230—
+10K223474PathLoc-TA Expandable Lumbar Cage SystemL&K BIOMED Co., Ltd.20231—
+10K213420WaveForm L System, WaveForm TO System, WaveForm TA SystemSeaSpine Orthopedics Corporation202211—
+10K212540Explorer TO SystemSeaSpine Orthopedics Corporation20213—
+10K203311ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20213—
+10K193636SeaSpine Reef TH SystemSeaSpine Orthopedics Corporation202056—
+11K262121Ion-L Navigated InstrumentsSurGenTec, LLC20260—
+11K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+11K261279DeltaNEC Interbody SystemNexus Spine20260—
+11K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+11K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+11K242829BluEX Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20240—
+11K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+11K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+11K223869ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20232—