Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
Spinal Elements, Inc. — Predicate Candidate Screening
49 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
115 daysmedian FDA review time
308 days90th percentile
49clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260506 | Ventana® P/T Lumbar Interbody System | Spinal Elements, Inc. | 2026-05-15 | 87 | 0 |
| K253559 | Ventana™ A Anterior Lumbar Interbody System | Spinal Elements, Inc. | 2026-02-25 | 100 | 0 |
| K250773 | Luna® Ti Interbody Fusion System | Spinal Elements, Inc. | 2026-02-04 | 327 | 0 |
| K242527 | The Karma® Fixation System | Spinal Elements, Inc. | 2025-05-21 | 268 | 0 |
| K243916 | Primus Spinal Fixation System | Spinal Elements, Inc. | 2025-02-21 | 63 | 0 |
| K231593 | Sapphire X3 Anterior Cervical Plate System | Spinal Elements, Inc. | 2023-08-02 | 62 | 0 |
| K231252 | Ventana™ L Spinal System | Spinal Elements, Inc. | 2023-06-30 | 60 | 0 |
| K222833 | Ventana™ C Spinal System | Spinal Elements, Inc. | 2023-05-19 | 241 | 0 |
| K222516 | Mercury® II Spinal System | Spinal Elements, Inc. | 2022-12-01 | 104 | 0 |
| K210044 | Crystal Spinal System & Vertu Spinal System, Lucent Spinal S | Spinal Elements, Inc. | 2021-06-30 | 174 | 0 |
| K203254 | Lucent 3D Spinal System | Spinal Elements, Inc. | 2021-03-26 | 142 | 0 |
| K202298 | Lucent XP, Lucent XP Curved | Spinal Elements, Inc. | 2020-12-22 | 131 | 0 |
| K201029 | Sapphire® Spinal System, Sapphire X Anterior Cervical Plate | Spinal Elements, Inc. | 2020-06-17 | 58 | 0 |
| K190881 | Spinal Elements Navigated Instruments | Spinal Elements, Inc. | 2019-12-19 | 259 | 0 |
| K191576 | Mercury® Spinal System, Overwatch® Spinal System | Spinal Elements, Inc. | 2019-09-16 | 94 | 0 |
| K190289 | Karma® Fixation System | Spinal Elements, Inc. | 2019-04-03 | 51 | 0 |
| K182584 | Lucent® XP | Spinal Elements, Inc. | 2018-12-10 | 81 | 0 |
| K181837 | Spinal Elements Ti-Bond coated devices | Spinal Elements, Inc. | 2018-11-02 | 115 | 0 |
| K180728 | Spinal Elements Cerclage System | Spinal Elements, Inc. | 2018-09-06 | 170 | 0 |
| K172967 | Mercury® Spinal System | Spinal Elements, Inc. | 2018-04-10 | 196 | 0 |
| K170235 | Lucent® | Spinal Elements, Inc. | 2017-11-29 | 308 | 0 |
| K153352 | Vertu® & Vertu® Ti-Bond and Crystal® & Crystal® Ti-Bond Cerv | Spinal Elements, Inc. | 2016-08-01 | 255 | 0 |
| K160465 | Spinal Elements' Spinous Process Plate System | Spinal Elements, Inc. | 2016-07-28 | 160 | 0 |
| K152011 | Lucent Intervertebral Body Fusion Device | Spinal Elements, Inc. | 2016-06-09 | 324 | 0 |
| K151705 | Lotus Posterior Cervical/Thoracic Spinal System | Spinal Elements, Inc. | 2015-09-03 | 71 | 0 |
| K151215 | Mercury Spinal System | Spinal Elements, Inc. | 2015-06-03 | 28 | 0 |
| K150061 | Lucent; Lucent Ti-Bond Systems | Spinal Elements, Inc. | 2015-05-19 | 126 | 0 |
| K133218 | Crystal ®; Mosaic ®; Vertu ® | Spinal Elements, Inc. | 2014-12-10 | 418 | 0 |
| K141372 | MERCURY SPINAL SYSTEM | Spinal Elements, Inc. | 2014-08-22 | 87 | 0 |
| K131427 | LOTUS | Spinal Elements, Inc. | 2013-10-24 | 160 | 0 |
| K122967 | LUCENT | Spinal Elements, Inc. | 2013-02-21 | 149 | 0 |
| K122771 | SPINAL ELEMENTS CERVICAL INTERVERTEBRAL BODY FUSION SYSTEM | Spinal Elements, Inc. | 2013-01-10 | 122 | 0 |
| K120467 | SPINAL ELEMENTS POSTERIOR CERVICAL/THORACIC SPINAL SYSTEM | Spinal Elements, Inc. | 2012-07-30 | 166 | 0 |
| K120177 | SPINAL ELEMENTS CERCLAGE SYSTEM | Spinal Elements, Inc. | 2012-07-03 | 165 | 0 |
| K110632 | LUCENT OR LUCENT MAGNUM | Spinal Elements, Inc. | 2012-05-23 | 446 | 1 |
| K101848 | SAPPHIRE ANTERIOR CERVICAL PLATE SYSTEM | Spinal Elements, Inc. | 2010-10-14 | 105 | 0 |
| K091587 | MERCURY SPINAL SYSTEM | Spinal Elements, Inc. | 2009-07-01 | 29 | 0 |
| K082992 | AXXION LIGHT GUIDE | Spinal Elements, Inc. | 2009-02-18 | 134 | 0 |
| K083475 | LUCENT MAGNUM | Spinal Elements, Inc. | 2009-02-13 | 81 | 0 |
| K082353 | MERCURY SPINAL SYSTEM | Spinal Elements, Inc. | 2009-01-22 | 160 | 0 |
| K083230 | MERCURY SPINAL SYSTEM | Spinal Elements, Inc. | 2008-12-03 | 30 | 0 |
| K081711 | LUCENT MAGNUM+ | Spinal Elements, Inc. | 2008-09-11 | 86 | 0 |
| K081968 | MODIFICATION TO LUCENT | Spinal Elements, Inc. | 2008-08-05 | 26 | 0 |
| K081418 | SPINAL ELEMENTS BUTTRESS PLATE SYSTEM | Spinal Elements, Inc. | 2008-07-14 | 55 | 0 |
| K073351 | CRYSTAL | Spinal Elements, Inc. | 2008-01-24 | 56 | 0 |
| K073348 | LUCENT MAGNUM | Spinal Elements, Inc. | 2007-12-26 | 27 | 0 |
| K071724 | LUCENT | Spinal Elements, Inc. | 2007-11-09 | 137 | 0 |
| K071833 | MOSAIC DEVICES | Spinal Elements, Inc. | 2007-10-23 | 112 | 0 |
| K071914 | MERCURY SPINAL SYSTEM | Spinal Elements, Inc. | 2007-10-12 | 93 | 22 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda