Cleared Abbreviated

K131880 - SPINEFRONTIER A-CIFT SOLOFUSE CERVICAL ...

K131880 is the FDA 510(k) clearance for SPINEFRONTIER A-CIFT SOLOFUSE CERVICAL ... by Spinefrontier, Inc.. It is a Class 2 Orthopedic device (product code OVE) cleared through the Abbreviated 510(k) pathway after a 192-day FDA review.

K131880 · Spinefrontier, Inc. · Orthopedic device
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Jan 2014
Decision
192d
Days
Class 2
Risk

K131880 is an FDA 510(k) clearance for the SPINEFRONTIER A-CIFT SOLOFUSE CERVICAL INTERVERTEBRAL FUSION DEVICE SYSTEM. Classified as Intervertebral Fusion Device With Integrated Fixation, Cervical (product code OVE), Class II - Special Controls.

Submitted by Spinefrontier, Inc. (Colorado Springs, US). The FDA issued a Cleared decision on January 3, 2014 after a review of 192 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3080 - the FDA orthopedic device regulatory framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Spinefrontier, Inc. devices

Submission Details

510(k) Number K131880 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 2013
Decision Date January 03, 2014
Days to Decision 192 days
Submission Type Abbreviated
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
70d slower than avg
Panel avg: 122d · This submission: 192d
Pathway characteristics
Standards-based clearance path.

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 111
Devices cleared under the same product code (OVE) and FDA review panel - the closest regulatory comparables to K131880.
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
COALITION SPACER
K131449 · Globus Medical, Inc. · Jul 2013
SPINAL ELEMENTS CERVICAL INTERVERTEBRAL BODY FUSION SYSTEM
K122771 · Spinal Elements, Inc. · Jan 2013
PRO-LINK CERVICAL SPACER SYSTEM
K121151 · Life Spine, Inc. · Nov 2012