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Spinal Elements, Inc

FDA Regulatory Profile

Summary

Total Recalls
24
510(k) Clearances
49
Inspections
10
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-1912-2018Class IIAMENDIA Omega Lumbar Interbody Fusion Device, Part Number 72-00-2-092812-11 The OmegaLIF(TM) (LIFApril 16, 2018
Z-1597-2015Class IIISpinal Elements 5.5 x 45MM Mercury lordosed rod. A component of the Mercury Spinal System, compriseApril 9, 2015
Z-0907-2015Class IITi-Bond Marketing Literature/Labeling, Catalog No. LT10000, MP-14000 This device is intended to be December 18, 2014
Z-1263-2013Class IIIMercury Spinal System DIA 5.5 x 100mm Straight Rod, Part Number: 60101-100. Intended to provide April 17, 2009
Z-1256-2013Class IIIMercury Spinal System DIA 5.5 x 30mm Straight Rod, Part Number: 60101-030. Intended to provide iApril 17, 2009
Z-1262-2013Class IIIMercury Spinal System DIA 5.5 x 90mm Straight Rod, Part Number: 60101-090. Intended to provide iApril 17, 2009
Z-1264-2013Class IIIMercury Spinal System DIA 5.5 x 110mm Straight Rod, Part Number: 60101-110. Intended to provide April 17, 2009
Z-1253-2013Class IIIMercury Spinal System DIA 5.5 x 100mm Lordosed Rod, Part Number: 60100-100. Intended to provide April 17, 2009
Z-1258-2013Class IIIMercury Spinal System DIA 5.5 x 50mm Straight Rod, Part Number: 60101-050. Intended to provide iApril 17, 2009
Z-1249-2013Class IIIMercury Spinal System DIA 5.5 x 60 MM Lordosed Rod, Part Number: 60100-060. Intended to provide April 17, 2009
Z-1266-2013Class IIIMercury Spinal System DIA 5.5 x 400mm Straight Rod, Part Number: 60101-400. Intended to provide April 17, 2009
Z-1254-2013Class IIIMercury Spinal System DIA 5.5 x 110mm Lordosed Rod, Part Number: 60100-110. Intended to provide April 17, 2009
Z-1252-2013Class IIIMercury Spinal System DIA 5.5 x 90 MM Lordosed Rod, Part Number: 60100-090. Intended to provide April 17, 2009
Z-1248-2013Class IIIMercury Spinal System DIA 5.5 x 50 MM Lordosed Rod, Part Number: 60100-050. Intended to provide April 17, 2009
Z-1247-2013Class IIIMercury Spinal System DIA 5.5 x 40 MM Lordosed Rod, Part Number: 60100-040. Intended to provideApril 17, 2009
Z-1261-2013Class IIIMercury Spinal System DIA 5.5 x 80mm Straight Rod, Part Number: 60101-080. Intended to provide iApril 17, 2009
Z-1265-2013Class IIIMercury Spinal System DIA 5.5 x 120mm Straight Rod, Part Number: 60101-120. Intended to provide April 17, 2009
Z-1257-2013Class IIIMercury Spinal System DIA 5.5 x 40mm Straight Rod, Part Number: 60101-040. Intended to provide iApril 17, 2009
Z-1246-2013Class IIIMercury Spinal System DIA 5.5 x 30 MM Lordosed Rod, Part Number: 60100-030. Intended to provideApril 17, 2009
Z-1250-2013Class IIIMercury Spinal System DIA 5.5 x 70 MM Lordosed Rod, Part Number: 60100-070. Intended to provide April 17, 2009

Recent 510(k) Clearances

K-NumberDeviceDate
K253559Ventana™ A Anterior Lumbar Interbody SystemFebruary 25, 2026
K250773Luna® Ti Interbody Fusion SystemFebruary 4, 2026
K242527The Karma® Fixation SystemMay 21, 2025
K243916Primus Spinal Fixation SystemFebruary 21, 2025
K234150Lucent® XPMarch 27, 2024
K231593Sapphire X3 Anterior Cervical Plate SystemAugust 2, 2023
K231252Ventana™ L Spinal SystemJune 30, 2023
K222833Ventana™ C Spinal SystemMay 19, 2023
K222516Mercury® II Spinal SystemDecember 1, 2022
K210044Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus Spinal System, Ceres-C SpinaJune 30, 2021
K203254Lucent 3D Spinal SystemMarch 26, 2021
K202298Lucent XP, Lucent XP CurvedDecember 22, 2020
K201029Sapphire® Spinal System, Sapphire X Anterior Cervical Plate Spinal SystemJune 17, 2020
K190881Spinal Elements Navigated InstrumentsDecember 19, 2019
K191576Mercury® Spinal System, Overwatch® Spinal SystemSeptember 16, 2019
K190289Karma® Fixation SystemApril 3, 2019
K182584Lucent® XPDecember 10, 2018
K181837Spinal Elements Ti-Bond coated devicesNovember 2, 2018
K180728Spinal Elements Cerclage SystemSeptember 6, 2018
K172967Mercury® Spinal SystemApril 10, 2018