510(k) Report

Devices descending from K142277

119 later devices reach Juliet PO through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+6K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+7K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+7K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+7K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+7K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+7K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+7K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+7K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+7K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+7K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+7K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+7K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+7K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+7K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+7K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+7K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+7K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+8K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—