Cleared Traditional

K261408 - SABER-XA System

K261408 is an FDA 510(k) clearance for SABER-XA System, manufactured by Elevation Spine. The device is a Class 2 Orthopedic device with product code OVD cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K261408 · Elevation Spine · Orthopedic device
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Aug 2026
Decision
95d
Days
Class 2
Risk

K261408 is an FDA 510(k) clearance for the SABER-XA System. Classified as Intervertebral Fusion Device With Integrated Fixation, Lumbar (product code OVD), Class II - Special Controls.

Submitted by Elevation Spine (Monteray, US). The FDA issued a Cleared decision on August 3, 2026 after a review of 95 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3080 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Elevation Spine devices

FDA 510(k) Submission Details - K261408

510(k) Number K261408 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 2026
Decision Date August 03, 2026
Days to Decision 95 days
Submission Type Traditional
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
27d faster than avg
Panel avg: 122d · This submission: 95d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OVD Device Classification - Class 2, Special Controls

Product Code OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3080
Definition 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.
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 - OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar

All 196
Devices cleared under the same product code (OVD) and FDA review panel - the closest regulatory comparables to K261408.
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K261809 · Foundation Surgical Group · Jul 2026
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K253559 · Spinal Elements, Inc. · Feb 2026
DeGen Medical Patient Specific Implant (PSI) System
K251829 · Degen Medical · Dec 2025