510(k) Report

Devices descending from K973060

129 later devices reach Depuy Motech Profile Anterior Thoracolumbar Plate System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K212811Ti3Z Lumbar Interbody SystemZavation Medical Products, LLC20223—
+7K220096Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20220—
+7K211306LabyrinthZavation Medical Products, LLC20213—
+7K210061ProLift Lateral HELO FixatedLife Spine, Inc.20213—
+7K191489Genesys Spine 3DP Cervical Interbody SystemGenesys Spine20207—
+8K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+8K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+8K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC20250—
+8K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+8K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+8K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—
+8K233594Genesys Spine 3DP AIS-C II Cervical Interbody SystemGenesys Spine20232—
+8K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+8K230731Zavation ALIF SystemZavation Medical Products, LLC20232—
+8K223335SIRION Lateral Lumbar Interbody SystemAstura Medical20230—
+8K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+9K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+9K250769Dakota LP SystemPrecision Spine, Inc.20250—
+9K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+9K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+9K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+9K242483Genesys Spine AIS-C II Cervical Interbody Fusion SystemGenesys Spine20250—
+9K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+9K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+9K230329F3D Interbody SystemCorelink, LLC20230—
+10K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+10K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+10K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+11K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—