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FDA 510(k)

SABER-C System

K-Number: K250540 · 2025-08-08

ApplicantElevation Spine
Decision Date2025-08-08
Product CodeOVE
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SABER-C System is a medical device manufactured by Elevation Spine. It received FDA 510(k) clearance on 2025-08-08 under approval number K250540. The device is classified under product code OVE. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SABER-C System?

SABER-C System is a medical device that received FDA 510(k) clearance on 2025-08-08. It is manufactured by Elevation Spine. The 510(k) number is K250540.

When was SABER-C System approved by the FDA?

SABER-C System received FDA 510(k) clearance on 2025-08-08, under approval number K250540.

What company makes SABER-C System?

SABER-C System is manufactured by Elevation Spine.

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

The FDA product code for SABER-C System is OVE.

Other Devices by Elevation Spine

K190885Elevation Spine Saber-C System K260660SABER-C System

Related Devices (Code: OVE)

K162531STERISPINE CCSafe Orthopaedics K162944Irix-C Cervical Integrated Fusion SystemX-Spine Systems, Inc. K160313Xenco Medical Cervical Interbody SystemXenco Medical, LLC K161442NuVasive® CoRoent® Small Interlock™ SystemNu Vasive, Incorporated K161081SeaSpine Shoreline ACS - Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation K160066Pro-Link® Stand-Alone Cervical Spacer SystemLife Spine, 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.

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