Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

49 results for "Spinal Elements, Inc."
1–24 of 49
Search insights Median review: 115d Cleared: 100% Top manufacturer: Spinal Elements, Inc. Lead specialty: Orthopedic
Cleared May 15, 2026
Ventana® P/T Lumbar Interbody System
K260506 · MAX
Spinal Elements, Inc.
Orthopedic · 87d
Cleared Feb 25, 2026
Ventana™ A Anterior Lumbar Interbody System
K253559 · OVD
Spinal Elements, Inc.
Orthopedic · 100d
Cleared Feb 04, 2026
Luna® Ti Interbody Fusion System
K250773 · MAX
Spinal Elements, Inc.
Orthopedic · 327d
Cleared May 21, 2025
The Karma® Fixation System
K242527 · MRW
Spinal Elements, Inc.
Orthopedic · 268d
Cleared Feb 21, 2025
Primus Spinal Fixation System
K243916 · NKB
Spinal Elements, Inc.
Orthopedic · 63d
Cleared Aug 02, 2023
Sapphire X3 Anterior Cervical Plate System
K231593 · KWQ
Spinal Elements, Inc.
Orthopedic · 62d
Cleared Jun 30, 2023
Ventana™ L Spinal System
K231252 · MAX
Spinal Elements, Inc.
Orthopedic · 60d
Cleared May 19, 2023
Ventana™ C Spinal System
K222833 · ODP
Spinal Elements, Inc.
Orthopedic · 241d
Cleared Dec 01, 2022
Mercury® II Spinal System
K222516 · NKB
Spinal Elements, Inc.
Orthopedic · 104d
Cleared Jun 30, 2021
Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus...
K210044 · MAX
Spinal Elements, Inc.
Orthopedic · 174d
Cleared Mar 26, 2021
Lucent 3D Spinal System
K203254 · MAX
Spinal Elements, Inc.
Orthopedic · 142d
Cleared Dec 22, 2020
Lucent XP, Lucent XP Curved
K202298 · MAX
Spinal Elements, Inc.
Orthopedic · 131d
Cleared Jun 17, 2020
Sapphire® Spinal System, Sapphire X Anterior Cervical Plate Spinal System
K201029 · KWQ
Spinal Elements, Inc.
Orthopedic · 58d
Cleared Dec 19, 2019
Spinal Elements Navigated Instruments
K190881 · OLO
Spinal Elements, Inc.
Orthopedic · 259d
Cleared Sep 16, 2019
Mercury® Spinal System, Overwatch® Spinal System
K191576 · NKB
Spinal Elements, Inc.
Orthopedic · 94d
Cleared Apr 03, 2019
Karma® Fixation System
K190289 · OWI
Spinal Elements, Inc.
Orthopedic · 51d
Cleared Dec 10, 2018
Lucent® XP
K182584 · MAX
Spinal Elements, Inc.
Orthopedic · 81d
Cleared Nov 02, 2018
Spinal Elements Ti-Bond coated devices
K181837 · MAX
Spinal Elements, Inc.
Orthopedic · 115d
Cleared Sep 06, 2018
Spinal Elements Cerclage System
K180728 · OWI
Spinal Elements, Inc.
Orthopedic · 170d
Cleared Apr 10, 2018
Mercury® Spinal System
K172967 · NKB
Spinal Elements, Inc.
Orthopedic · 196d
Cleared Nov 29, 2017
Lucent®
K170235 · MAX
Spinal Elements, Inc.
Orthopedic · 308d
Cleared Aug 01, 2016
Vertu® & Vertu® Ti-Bond and Crystal® & Crystal® Ti-Bond Cervical Interbody...
K153352 · OVE
Spinal Elements, Inc.
Orthopedic · 255d
Cleared Jul 28, 2016
Spinal Elements' Spinous Process Plate System
K160465 · PEK
Spinal Elements, Inc.
Orthopedic · 160d
Cleared Jun 09, 2016
Lucent Intervertebral Body Fusion Device
K152011 · MAX
Spinal Elements, Inc.
Orthopedic · 324d