510(k) Report

Devices descending from K061016

525 later devices reach Ebi Esl Peek-Optima Spine System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+11K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+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—
+11K241467Stable-C Interbody SystemNexus Spine, LLC20242—
+11K240416Tranquil-C Interbody SystemNexus Spine, LLC20243—
+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—
+12K261279DeltaNEC Interbody SystemNexus Spine20260—
+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—