510(k) Report

Devices descending from K150135

228 later devices reach DIVERGENCE-L Anterior/Oblique Lumbar Fusion System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K233414Shoreline ACS Interbody System; Shoreline RT Interbody SystemSeaSpine Orthopedics Corporation20238—
+6K232822Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system), Anterior…Gbs Commonwealth Co., Ltd.20232—
+6K230414ClariVy™ Cervical IBF SystemVy Spine, LLC20233—
+6K223474PathLoc-TA Expandable Lumbar Cage SystemL&K BIOMED Co., Ltd.20231—
+6K220711SeaSpine Meridian System, SeaSpine Meridian Anterior Plate SystemSeaSpine Orthopedics Corporation202210—
+6K213420WaveForm L System, WaveForm TO System, WaveForm TA SystemSeaSpine Orthopedics Corporation202211—
+6K212540Explorer TO SystemSeaSpine Orthopedics Corporation20213—
+6K210583SeaSpine WaveForm™ A Interbody SystemSeaSpine Orthopedics Corporation202114—
+6K203311ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20213—
+6K193636SeaSpine Reef TH SystemSeaSpine Orthopedics Corporation202056—
+7K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+7K261279DeltaNEC Interbody SystemNexus Spine20260—
+7K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.20260—
+7K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+7K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+7K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+7K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+7K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+7K242829BluEX Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20240—
+7K240699SCARLET® AC-TiSpineart SA20240—
+7K233839Peridot-PT Anterior Cervical Intervertebral body fusion System; Peridot-PT…Gbs Commonwealth Co., Ltd.20231—
+7K231836ClariVy™ Cervical IBF SystemVy Spine, LLC20232—
+7K223869ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20232—
+7K222732WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20229—
+8K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+8K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+8K243915FIX-C 3D Ti ACIF SystemJeil Medical Corporation20250—
+9K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—