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Spinal Elements, Inc.

49 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
Ventana® P/T Lumbar Interbody System (K260506)Spinal Elements, Inc.2026-05-15
Ventana™ A Anterior Lumbar Interbody System (K253559)Spinal Elements, Inc.2026-02-25
Luna® Ti Interbody Fusion System (K250773)Spinal Elements, Inc.2026-02-04
The Karma® Fixation System (K242527)Spinal Elements, Inc.2025-05-21
Primus Spinal Fixation System (K243916)Spinal Elements, Inc.2025-02-21
Sapphire X3 Anterior Cervical Plate System (K231593)Spinal Elements, Inc.2023-08-02
Ventana™ L Spinal System (K231252)Spinal Elements, Inc.2023-06-30
Ventana™ C Spinal System (K222833)Spinal Elements, Inc.2023-05-19
Mercury® II Spinal System (K222516)Spinal Elements, Inc.2022-12-01
Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus Spinal System, Ceres-C Spinal System, Omega XP Spinal System (K210044)Spinal Elements, Inc.2021-06-30
Lucent 3D Spinal System (K203254)Spinal Elements, Inc.2021-03-26
Lucent XP, Lucent XP Curved (K202298)Spinal Elements, Inc.2020-12-22
Sapphire® Spinal System, Sapphire X Anterior Cervical Plate Spinal System (K201029)Spinal Elements, Inc.2020-06-17
Spinal Elements Navigated Instruments (K190881)Spinal Elements, Inc.2019-12-19
Mercury® Spinal System, Overwatch® Spinal System (K191576)Spinal Elements, Inc.2019-09-16
Karma® Fixation System (K190289)Spinal Elements, Inc.2019-04-03
Lucent® XP (K182584)Spinal Elements, Inc.2018-12-10
Spinal Elements Ti-Bond coated devices (K181837)Spinal Elements, Inc.2018-11-02
Spinal Elements Cerclage System (K180728)Spinal Elements, Inc.2018-09-06
Mercury® Spinal System (K172967)Spinal Elements, Inc.2018-04-10
Lucent® (K170235)Spinal Elements, Inc.2017-11-29
Vertu® & Vertu® Ti-Bond and Crystal® & Crystal® Ti-Bond Cervical Interbody System (K153352)Spinal Elements, Inc.2016-08-01
Spinal Elements' Spinous Process Plate System (K160465)Spinal Elements, Inc.2016-07-28
Lucent Intervertebral Body Fusion Device (K152011)Spinal Elements, Inc.2016-06-09
Lotus Posterior Cervical/Thoracic Spinal System (K151705)Spinal Elements, Inc.2015-09-03
Mercury Spinal System (K151215)Spinal Elements, Inc.2015-06-03
Lucent; Lucent Ti-Bond Systems (K150061)Spinal Elements, Inc.2015-05-19
Crystal ®; Mosaic ®; Vertu ® (K133218)Spinal Elements, Inc.2014-12-10
MERCURY SPINAL SYSTEM (K141372)Spinal Elements, Inc.2014-08-22
LOTUS (K131427)Spinal Elements, Inc.2013-10-24
LUCENT (K122967)Spinal Elements, Inc.2013-02-21
SPINAL ELEMENTS CERVICAL INTERVERTEBRAL BODY FUSION SYSTEM (K122771)Spinal Elements, Inc.2013-01-10
SPINAL ELEMENTS POSTERIOR CERVICAL/THORACIC SPINAL SYSTEM (K120467)Spinal Elements, Inc.2012-07-30
SPINAL ELEMENTS CERCLAGE SYSTEM (K120177)Spinal Elements, Inc.2012-07-03
LUCENT OR LUCENT MAGNUM (K110632)Spinal Elements, Inc.2012-05-23
SAPPHIRE ANTERIOR CERVICAL PLATE SYSTEM (K101848)Spinal Elements, Inc.2010-10-14
MERCURY SPINAL SYSTEM (K091587)Spinal Elements, Inc.2009-07-01
AXXION LIGHT GUIDE (K082992)Spinal Elements, Inc.2009-02-18
LUCENT MAGNUM (K083475)Spinal Elements, Inc.2009-02-13
MERCURY SPINAL SYSTEM (K082353)Spinal Elements, Inc.2009-01-22
MERCURY SPINAL SYSTEM (K083230)Spinal Elements, Inc.2008-12-03
LUCENT MAGNUM+ (K081711)Spinal Elements, Inc.2008-09-11
MODIFICATION TO LUCENT (K081968)Spinal Elements, Inc.2008-08-05
SPINAL ELEMENTS BUTTRESS PLATE SYSTEM (K081418)Spinal Elements, Inc.2008-07-14
CRYSTAL (K073351)Spinal Elements, Inc.2008-01-24
LUCENT MAGNUM (K073348)Spinal Elements, Inc.2007-12-26
LUCENT (K071724)Spinal Elements, Inc.2007-11-09
MOSAIC DEVICES (K071833)Spinal Elements, Inc.2007-10-23
MERCURY SPINAL SYSTEM (K071914)Spinal Elements, Inc.2007-10-12

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Every clearance here is in the API, with alerts when new ones post.