Spinal Elements, Inc.

Code	Device name	Class	Specialty	Clearances	Most recent
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Class II	Orthopedic	7	2026-05-15
NKB	Thoracolumbosacral Pedicle Screw System	Class II	Orthopedic	2	2025-02-21
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Class II	Orthopedic	2	2023-08-02
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Class II	Orthopedic	1	2026-02-25
MRW	System, Facet Screw Spinal Device	Unclassified	Unknown	1	2025-05-21
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Class II	Orthopedic	1	2023-05-19

Date	K-number	Device	Code	Class	Specialty
2026-05-15	K260506	Ventana® P/T Lumbar Interbody System	MAX	Class II	Orthopedic
2026-02-25	K253559	Ventana A Anterior Lumbar Interbody System	OVD	Class II	Orthopedic
2026-02-04	K250773	Luna® Ti Interbody Fusion System	MAX	Class II	Orthopedic
2025-05-21	K242527	The Karma® Fixation System	MRW	Unclassified	Unknown
2025-02-21	K243916	Primus Spinal Fixation System	NKB	Class II	Orthopedic
2024-03-27	K234150	Lucent® XP	MAX	Class II	Orthopedic
2023-08-02	K231593	Sapphire X3 Anterior Cervical Plate System	KWQ	Class II	Orthopedic
2023-06-30	K231252	Ventana L Spinal System	MAX	Class II	Orthopedic
2023-05-19	K222833	Ventana C Spinal System	ODP	Class II	Orthopedic
2022-12-01	K222516	Mercury® II Spinal System	NKB	Class II	Orthopedic
2021-06-30	K210044	Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus Spinal System, Ceres-C Spinal System, Omega XP Spinal System	MAX	Class II	Orthopedic
2021-03-26	K203254	Lucent 3D Spinal System	MAX	Class II	Orthopedic
2020-12-22	K202298	Lucent XP, Lucent XP Curved	MAX	Class II	Orthopedic
2020-06-17	K201029	Sapphire® Spinal System, Sapphire X Anterior Cervical Plate Spinal System	KWQ	Class II	Orthopedic

Clearance cadence by quarter