510(k) Report

Devices descending from K121852

30 later devices reach Synthes Zero-P Variable Angle (VA) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K141005Z-Link CervicalZavation, LLC20144—
+1K131429Reliance Cervical Ibf SystemReliance Medical Systems, LLC201324—
+2K202266Reliance Cervical IBF SystemReliance Medical Systems, LLC20223—
+2K173102Reliance Cervical IBF SystemReliance Medical Systems, LLC201715—
+2K152972Amendia Stand-Alone Cervical SystemAmendia, Inc.201632
+2K142269Reliance Cervical IBF SystemReliance Medical Systems, LLC201523—
+3K221162UniVy OsteoVy Cervical IBF SystemVy Spine, LLC20222—
+3K212358Romero Cervical CageSpineup, Inc.20226—
+3K212715Vy Spine ClariVy Cervical IBF SystemVy Spine, LLC20216—
+3K210382Blustone Synergy Diamond SA Cervical SystemBlustone Synergy, LLC20210—
+3K210044Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus Spinal System…Spinal Elements, Inc.20211—
+3K172489Reliance Cervical IBF SystemReliance Medical Systems, LLC201716—
+3K161809ShurFit CpTi-HA ACIF Interbody Fusion SystemPrecision Spine, Inc.20165—
+4K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+4K233807LumiVy™ Lumbar IBF SystemVy Spine, LLC20241—
+4K240893ARTFX MEDICAL Cervical PEEK CagesArtfx Medical20244—
+4K231836ClariVy™ Cervical IBF SystemVy Spine, LLC20232—
+4K230607SPICCA Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+4K230414ClariVy™ Cervical IBF SystemVy Spine, LLC20233—
+4K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+4K230026SqualeImplanet, S.A.20230—
+4K171657ShurFit 2C Lumbar Interbody Fusion SystemPrecision Spine, Inc.20174—
+5K260340HC Biologics Osteopoint Peek Cages, HC Biologics Osteopoint Cervical Peek Cages, HC…HC Biologics, LLC20260—
+5K252686EffortMed PEEK Cages & Corpectomy CagesEffortmed, LLC20251—
+5K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+5K221182Southern Transforaminal Lumbar Interbody Fusion (TLIF)Southern Medical (Pty), Ltd.20220—
+5K212075ShurFit Lumbar Interbody SystemPrecision Spine, Inc.20211—
+5K212070KMTI S141 Lumbar Interbody Fusion SystemKyocera Medical Technologies, Inc.20210—
+6K260850Osteomni Spinal Cages SystemOsteomni, Inc.20260—
+6K221172FOCUS Interbody SystemOc Medical Devices20220—