510(k) Report

Devices descending from K171686

116 later devices reach Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+7K241846E3D™-C Interbody SystemEvolution Spine20246—
+7K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+7K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+7K233694Meridian Interbody System; WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20248—
+7K222732WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20229—
+7K220523restor3d TiDAL Lumbar Interbody Fusion DeviceRestor3D20222—
+8K262094E3D™-C Interbody SystemEvolution Spine20260—
+8K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+8K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+8K260038E3D™-C Interbody SystemEvolution Spine20261—
+8K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+8K240749PILLAR SA Ti Spacer System (82-XXX)Orthofix, Inc.202402
+8K234087restor3d TIDAL Lumbar Interbody Fusion SystemRestor3D20240—
+8K223326Axiom PSR SystemRestor3D202301
+9K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—