Cleared Traditional

K262726 - NeckTune™ SA Cervical Cage

K262726 is an FDA 510(k) clearance for NeckTune SA Cervical Cage, manufactured by Medyssey Co, Ltd.. The device is a Class 2 Orthopedic device with product code OVE cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K262726 · Medyssey Co, Ltd. · Orthopedic device
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Sep 2026
Decision
60d
Days
Class 2
Risk

K262726 is an FDA 510(k) clearance for the NeckTune™ SA Cervical Cage. Classified as Intervertebral Fusion Device With Integrated Fixation, Cervical (product code OVE), Class II - Special Controls.

Submitted by Medyssey Co, Ltd. (Jecheon-Si, KR). The FDA issued a Cleared decision on September 29, 2026 after a review of 60 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Medyssey Co, Ltd. devices

FDA 510(k) Submission Details - K262726

510(k) Number K262726 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 2026
Decision Date September 29, 2026
Days to Decision 60 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
62d faster than avg
Panel avg: 122d · This submission: 60d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 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 K262726.
ZSAlign Cervical Interbody System
K263113 · Zsfab, Inc. · Oct 2026
SABER-C System
K263049 · Elevation Spine · 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