SABER-C System

FDA 510(k) K260660 · Elevation Spine

Substantially Equivalent

510(k) numberK260660

Submission

Device name
SABER-C System
Applicant
Elevation Spine
Monteray, CA, US
Received
March 2, 2026
Decision date
April 27, 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
OVE – Intervertebral Fusion Device With Integrated Fixation, Cervical
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3080
Specialty
Orthopedic
Implant
Yes

Intended to stabilize cervical 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 OVE

510(k)DeviceApplicantDecision
K261882Pisces-SC Standalone Cervical Interbody SystemOVE · Traditional Osseus Fusions Systems, LLC08/21/2026SE
K261451ZSAlign Cervical Interbody SystemOVE · Traditional ZSFab, Inc.07/31/2026SE
K262094E3D™-C Interbody SystemOVE · Special Evolution Spine07/22/2026SE
K261279DeltaNEC Interbody SystemOVE · Traditional Nexus Spine06/22/2026SE
K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemOVE · Traditional Avalign Technologies, Inc.06/18/2026SE
K260036NeckTune™ 3D SA Cervical CageOVE · Traditional Medyssey Co, Ltd.06/15/2026SE
K253213SAGI Cervical Cage SystemOVE · Traditional ZheJiang Decans Medical Devices Co., Ltd.04/20/2026SE
K252774Uni-C Cervical Cage SystemOVE · Traditional ZheJiang Decans Medical Devices Co., Ltd.04/15/2026SE
K260038E3D™-C Interbody SystemOVE · Special Evolution Spine02/04/2026SE
K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)OVE · Special Globus Medical, Inc.12/22/2025SE

More from Globus Medical, Inc.

510(k)DeviceDecision
K261408SABER-XA SystemOVD · Traditional 08/03/2026SE
K250540SABER-C SystemOVE · Traditional 08/08/2025SE
K190885Elevation Spine Saber-C SystemOVE · Traditional 08/07/2019SE

Questions and answers

When was SABER-C System cleared by the FDA?

SABER-C System (K260660) received a 510(k) decision of Substantially Equivalent on April 27, 2026, 56 days after the submission was received.

What is the product code of K260660?

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