SABER-XA System

Q: When was SABER-XA System cleared by the FDA?

SABER-XA System (K261408) received a 510(k) decision of Substantially Equivalent on August 3, 2026, 95 days after the submission was received.

Q: What is the product code of K261408?

The FDA product code is OVD – Intervertebral Fusion Device With Integrated Fixation, Lumbar, a Class II (moderate risk) device regulated under 21 CFR 888.3080.

FDA 510(k) K261408 · Elevation Spine

Substantially Equivalent

510(k) numberK261408

Submission

Device name: SABER-XA System
Applicant: Elevation Spine
Monteray, CA, US
Received: April 30, 2026
Decision date: August 3, 2026
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: OVD – Intervertebral Fusion Device With Integrated Fixation, Lumbar
Device class: Class II (moderate risk)
Regulation: 21 CFR 888.3080
Specialty: Orthopedic
Implant: Yes

Intended to stabilize lumbar spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft with or without supplemental fixation.

Other 510(k)s with product code OVD

510(k)	Device	Applicant	Decision
K262025	Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis…OVD · Traditional	INNO Holdings Inc. DBA Innovasis	09/11/2026SE
K261809	Interwedge® Standalone LateralOVD · Special	Foundation Surgical Group	07/31/2026SE
K261353	Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…OVD · Traditional	Kyocera Medical Technologies, Inc.	07/15/2026SE
K260810	Anteralign LS coverplateOVD · Traditional	Tyber Medical, LLC	06/10/2026SE
K254202	MectaLIF 3D Metal AnteriorOVD · Traditional	Medacta International S.A.	05/05/2026SE
K253401	SCRIPT Implant SystemOVD · Traditional	Globus Medical, Inc.	04/29/2026SE
K253559	Ventana A Anterior Lumbar Interbody SystemOVD · Traditional	Spinal Elements, Inc.	02/25/2026SE
K251829	DeGen Medical Patient Specific Implant (PSI) SystemOVD · Traditional	Degen Medical	12/08/2025SE
K251575	IdentiTi II ALIF Standalone Interbody System; Transcend ALIF Standalone Interbody SystemOVD · Traditional	Alphatec Spine	09/03/2025SE
K250072	CONDUIT SYNFIX Evolution Secured Spacer SystemOVD · Traditional	Avalign Technologies, Inc.	07/10/2025SE

More from Avalign Technologies, Inc.

510(k)	Device	Decision
K260660	SABER-C SystemOVE · Traditional	04/27/2026SE
K250540	SABER-C SystemOVE · Traditional	08/08/2025SE
K190885	Elevation Spine Saber-C SystemOVE · Traditional	08/07/2019SE

Questions and answers

When was SABER-XA System cleared by the FDA?

SABER-XA System (K261408) received a 510(k) decision of Substantially Equivalent on August 3, 2026, 95 days after the submission was received.

What is the product code of K261408?

The FDA product code is OVD – Intervertebral Fusion Device With Integrated Fixation, Lumbar, a Class II (moderate risk) device regulated under 21 CFR 888.3080.