Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

SABER-XA System

K-Number: K261408 · 2026-08-03

ApplicantElevation Spine
Decision Date2026-08-03
Product CodeOVD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SABER-XA System is the device name listed in this FDA 510(k) record. The listed applicant is Elevation Spine. It received FDA 510(k) clearance on 2026-08-03 under 510(k) number K261408. The device is classified under product code OVD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SABER-XA System?

SABER-XA System is a medical device that received FDA 510(k) clearance on 2026-08-03. The listed applicant is Elevation Spine. The 510(k) number is K261408.

When did SABER-XA System receive FDA 510(k) clearance?

SABER-XA System received FDA 510(k) clearance on 2026-08-03, under 510(k) number K261408.

Who is the listed applicant for SABER-XA System?

The FDA 510(k) record lists Elevation Spine as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SABER-XA System?

The FDA product code for SABER-XA System is OVD.

Other records listing Elevation Spine as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260660SABER-C SystemK250540SABER-C SystemK190885Elevation Spine Saber-C System

Related Devices (Code: OVD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261809Interwedge® Standalone LateralFoundation Surgical GroupK261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar Anchor SystemKyocera Medical Technologies, Inc.K260810Anteralign LS coverplateTyber Medical, LLCK254202MectaLIF 3D Metal AnteriorMedacta International S.A.K253401SCRIPT™ Implant SystemGlobus Medical, Inc.K253559Ventana™ A Anterior Lumbar Interbody SystemSpinal Elements, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑