Cleared Special

K263049 - SABER-C System

K263049 is an FDA 510(k) clearance for SABER-C System, manufactured by Elevation Spine. The device is a Class 2 Orthopedic device with product code OVE cleared through the Special 510(k) pathway after a 23-day FDA review.

K263049 · Elevation Spine · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2026
Decision
23d
Days
Class 2
Risk

K263049 is an FDA 510(k) clearance for the SABER-C System. Classified as Intervertebral Fusion Device With Integrated Fixation, Cervical (product code OVE), Class II - Special Controls.

Submitted by Elevation Spine (Monteray, US). The FDA issued a Cleared decision on September 23, 2026 after a review of 23 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3080 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Elevation Spine devices

FDA 510(k) Submission Details - K263049

510(k) Number K263049 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 2026
Decision Date September 23, 2026
Days to Decision 23 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
99d faster than avg
Panel avg: 122d · This submission: 23d
Pathway characteristics
Modification to existing cleared device.

OVE Device Classification - Class 2, Special Controls

Product Code OVE Intervertebral Fusion Device With Integrated Fixation, Cervical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3080
Definition 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Consultant

MRC Global, LLC
Jen McBride

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - OVE Intervertebral Fusion Device With Integrated Fixation, Cervical

All 168
Devices cleared under the same product code (OVE) and FDA review panel - the closest regulatory comparables to K263049.
ZSAlign Cervical Interbody System
K263113 · Zsfab, Inc. · Oct 2026
NeckTune™ SA Cervical Cage
K262726 · Medyssey Co, Ltd. · Sep 2026
Pisces-SC Standalone Cervical Interbody System
K261882 · Osseus Fusions Systems, LLC · Aug 2026
ZSAlign Cervical Interbody System
K261451 · Zsfab, Inc. · Jul 2026
E3D™-C Interbody System
K262094 · Evolution Spine · Jul 2026
DeltaNEC Interbody System
K261279 · Nexus Spine · Jun 2026