Cleared Traditional

K142079 - STALIF CTI

K142079 is the FDA 510(k) clearance for STALIF CTI by Centinel Spine, Inc.. It is a Class 2 Orthopedic device (product code OVE) cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K142079 · Centinel Spine, Inc. · Orthopedic device
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Oct 2014
Decision
85d
Days
Class 2
Risk

K142079 is an FDA 510(k) clearance for the STALIF CTI, STALIF C. Classified as Intervertebral Fusion Device With Integrated Fixation, Cervical (product code OVE), Class II - Special Controls.

Submitted by Centinel Spine, Inc. (Washington, US). The FDA issued a Cleared decision on October 24, 2014 after a review of 85 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 Centinel Spine, Inc. devices

Submission Details

510(k) Number K142079 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 2014
Decision Date October 24, 2014
Days to Decision 85 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 122d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 115
Devices cleared under the same product code (OVE) and FDA review panel - the closest regulatory comparables to K142079.
DIVERGENCE ANTERIOR CERVICAL FUSION SYSTEM
K141599 · Medtronic Sofamor Danek USA, Inc. · Jan 2015
Crystal ®
K133218 · Spinal Elements, Inc. · Dec 2014
CoRoent Small Interlock System
K142299 · Nu Vasive, Incorporated · Nov 2014
SCARLET AC-T SECURED ANTERIOR CERVICAL CAGE AND ASSOCIATED INSTRUMENTATION
K141314 · Spineart · Sep 2014
CERVICAL STAND ALONE SYSTEM
K132999 · Orthofix, Inc. · Apr 2014
EXACTECH ACAPELLA ONE CERVICAL SPACER SYSTEM
K132582 · Exactech, Inc. · Feb 2014