510(k) Report

Devices descending from K050861

224 later devices reach Peek Cas through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+12K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+12K222383Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Technology MAZORX Stealth (TM)…Medtronic Sofamor Danek USA, Inc.20220—
+12K220711SeaSpine Meridian System, SeaSpine Meridian Anterior Plate SystemSeaSpine Orthopedics Corporation202210—
+12K210583SeaSpine WaveForm™ A Interbody SystemSeaSpine Orthopedics Corporation202114—
+13K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+13K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+13K261060Navigated LLIF Impactable TrackerTyber Medical, LLC20260—
+13K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+13K252322SIros-X SystemGenesys Spine20250—
+13K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+13K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+13K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+13K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+13K241846E3D™-C Interbody SystemEvolution Spine20246—
+13K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+13K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+13K233694Meridian Interbody System; WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20248—
+13K222732WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20229—
+14K262094E3D™-C Interbody SystemEvolution Spine20260—
+14K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+14K260038E3D™-C Interbody SystemEvolution Spine20261—
+14K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+14K240749PILLAR SA Ti Spacer System (82-XXX)Orthofix, Inc.202402
+15K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—