510(k) Report

Devices descending from K031276

128 later devices reach Synthes Anterior Cervical Locking Plate (Aclp) System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+7K221162UniVy OsteoVy Cervical IBF SystemVy Spine, LLC20222—
+7K221728Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System, DynaTran™ Anterior…Stryker Corporation20221—
+7K212358Romero Cervical CageSpineup, Inc.20226—
+7K212715Vy Spine ClariVy Cervical IBF SystemVy Spine, LLC20216—
+7K210382Blustone Synergy Diamond SA Cervical SystemBlustone Synergy, LLC20210—
+7K210044Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus Spinal System…Spinal Elements, Inc.20211—
+7K172489Reliance Cervical IBF SystemReliance Medical Systems, LLC201716—
+7K161809ShurFit CpTi-HA ACIF Interbody Fusion SystemPrecision Spine, Inc.20165—
+8K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—
+8K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+8K233807LumiVy™ Lumbar IBF SystemVy Spine, LLC20241—
+8K240893ARTFX MEDICAL Cervical PEEK CagesArtfx Medical20244—
+8K231836ClariVy™ Cervical IBF SystemVy Spine, LLC20232—
+8K230607SPICCA Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+8K230414ClariVy™ Cervical IBF SystemVy Spine, LLC20233—
+8K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+8K230424Omnia Medical Coupler-A™ Anterior Lumbar Plate System; Omnia Medical Coupler-L™ Lateral…Omnia Medical, LLC20230—
+8K230026SqualeImplanet, S.A.20230—
+8K171657ShurFit 2C Lumbar Interbody Fusion SystemPrecision Spine, Inc.20174—
+9K260340HC Biologics Osteopoint Peek Cages, HC Biologics Osteopoint Cervical Peek Cages, HC…HC Biologics, LLC20260—
+9K252686EffortMed PEEK Cages & Corpectomy CagesEffortmed, LLC20251—
+9K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+9K221182Southern Transforaminal Lumbar Interbody Fusion (TLIF)Southern Medical (Pty), Ltd.20220—
+9K212075ShurFit Lumbar Interbody SystemPrecision Spine, Inc.20211—
+9K212070KMTI S141 Lumbar Interbody Fusion SystemKyocera Medical Technologies, Inc.20210—
+10K260850Osteomni Spinal Cages SystemOsteomni, Inc.20260—
+10K221172FOCUS Interbody SystemOc Medical Devices20220—