Spinal Elements, Inc
FDA Regulatory Profile
Spinal Elements, Inc appears in FDA public data with 24 recalls, 50 510(k) clearances, 10 FDA inspections, and 1 compliance action on record. Its most recent recall (Z-1912-2018, Class II) was initiated on April 16, 2018. Its most recent 510(k) clearance was granted on May 15, 2026.
Summary
- Total Recalls
- 24
- 510(k) Clearances
- 50
- Inspections
- 10
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1912-2018 | Class II | AMENDIA Omega Lumbar Interbody Fusion Device, Part Number 72-00-2-092812-11 The OmegaLIF(TM) (LIF | April 16, 2018 |
| Z-1597-2015 | Class III | Spinal Elements 5.5 x 45MM Mercury lordosed rod. A component of the Mercury Spinal System, comprise | April 9, 2015 |
| Z-0907-2015 | Class II | Ti-Bond Marketing Literature/Labeling, Catalog No. LT10000, MP-14000 This device is intended to be | December 18, 2014 |
| Z-1264-2013 | Class III | Mercury Spinal System DIA 5.5 x 110mm Straight Rod, Part Number: 60101-110. Intended to provide | April 17, 2009 |
| Z-1263-2013 | Class III | Mercury Spinal System DIA 5.5 x 100mm Straight Rod, Part Number: 60101-100. Intended to provide | April 17, 2009 |
| Z-1251-2013 | Class III | Mercury Spinal System DIA 5.5 x 80 MM Lordosed Rod, Part Number: 60100-080. Intended to provide | April 17, 2009 |
| Z-1261-2013 | Class III | Mercury Spinal System DIA 5.5 x 80mm Straight Rod, Part Number: 60101-080. Intended to provide i | April 17, 2009 |
| Z-1265-2013 | Class III | Mercury Spinal System DIA 5.5 x 120mm Straight Rod, Part Number: 60101-120. Intended to provide | April 17, 2009 |
| Z-1258-2013 | Class III | Mercury Spinal System DIA 5.5 x 50mm Straight Rod, Part Number: 60101-050. Intended to provide i | April 17, 2009 |
| Z-1253-2013 | Class III | Mercury Spinal System DIA 5.5 x 100mm Lordosed Rod, Part Number: 60100-100. Intended to provide | April 17, 2009 |
| Z-1259-2013 | Class III | Mercury Spinal System DIA 5.5 x 60mm Straight Rod, Part Number: 60101-060. Intended to provide i | April 17, 2009 |
| Z-1260-2013 | Class III | Mercury Spinal System DIA 5.5 x 70mm Straight Rod, Part Number: 60101-070. Intended to provide i | April 17, 2009 |
| Z-1257-2013 | Class III | Mercury Spinal System DIA 5.5 x 40mm Straight Rod, Part Number: 60101-040. Intended to provide i | April 17, 2009 |
| Z-1255-2013 | Class III | Mercury Spinal System DIA 5.5 x 120mm Lordosed Rod, Part Number: 60100-120. Intended to provide | April 17, 2009 |
| Z-1250-2013 | Class III | Mercury Spinal System DIA 5.5 x 70 MM Lordosed Rod, Part Number: 60100-070. Intended to provide | April 17, 2009 |
| Z-1246-2013 | Class III | Mercury Spinal System DIA 5.5 x 30 MM Lordosed Rod, Part Number: 60100-030. Intended to provide | April 17, 2009 |
| Z-1252-2013 | Class III | Mercury Spinal System DIA 5.5 x 90 MM Lordosed Rod, Part Number: 60100-090. Intended to provide | April 17, 2009 |
| Z-1256-2013 | Class III | Mercury Spinal System DIA 5.5 x 30mm Straight Rod, Part Number: 60101-030. Intended to provide i | April 17, 2009 |
| Z-1262-2013 | Class III | Mercury Spinal System DIA 5.5 x 90mm Straight Rod, Part Number: 60101-090. Intended to provide i | April 17, 2009 |
| Z-1248-2013 | Class III | Mercury Spinal System DIA 5.5 x 50 MM Lordosed Rod, Part Number: 60100-050. Intended to provide | April 17, 2009 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K260506 | Ventana® P/T Lumbar Interbody System | May 15, 2026 |
| K253559 | Ventana A Anterior Lumbar Interbody System | February 25, 2026 |
| K250773 | Luna® Ti Interbody Fusion System | February 4, 2026 |
| K242527 | The Karma® Fixation System | May 21, 2025 |
| K243916 | Primus Spinal Fixation System | February 21, 2025 |
| K234150 | Lucent® XP | March 27, 2024 |
| K231593 | Sapphire X3 Anterior Cervical Plate System | August 2, 2023 |
| K231252 | Ventana L Spinal System | June 30, 2023 |
| K222833 | Ventana C Spinal System | May 19, 2023 |
| K222516 | Mercury® II Spinal System | December 1, 2022 |
| K210044 | Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus Spinal System, Ceres-C Spina | June 30, 2021 |
| K203254 | Lucent 3D Spinal System | March 26, 2021 |
| K202298 | Lucent XP, Lucent XP Curved | December 22, 2020 |
| K201029 | Sapphire® Spinal System, Sapphire X Anterior Cervical Plate Spinal System | June 17, 2020 |
| K190881 | Spinal Elements Navigated Instruments | December 19, 2019 |
| K191576 | Mercury® Spinal System, Overwatch® Spinal System | September 16, 2019 |
| K190289 | Karma® Fixation System | April 3, 2019 |
| K182584 | Lucent® XP | December 10, 2018 |
| K181837 | Spinal Elements Ti-Bond coated devices | November 2, 2018 |
| K180728 | Spinal Elements Cerclage System | September 6, 2018 |