Cleared Traditional

K141337 - ARENA-C

K141337 is an FDA 510(k) clearance for ARENA-C, manufactured by Spinefrontier, Inc.. The device is a Class 2 Orthopedic device with product code ODP cleared through the Traditional 510(k) pathway after a 110-day FDA review.

K141337 · Spinefrontier, Inc. · Orthopedic device
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Sep 2014
Decision
110d
Days
Class 2
Risk

K141337 is an FDA 510(k) clearance for the ARENA-C. Classified as Intervertebral Fusion Device With Bone Graft, Cervical (product code ODP), Class II - Special Controls.

Submitted by Spinefrontier, Inc. (Colorado Springs, US). The FDA issued a Cleared decision on September 8, 2014 after a review of 110 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 Spinefrontier, Inc. devices

FDA 510(k) Submission Details - K141337

510(k) Number K141337 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 2014
Decision Date September 08, 2014
Days to Decision 110 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
12d faster than avg
Panel avg: 122d · This submission: 110d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ODP Device Classification - Class 2, Special Controls

Product Code ODP Intervertebral Fusion Device With Bone Graft, 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.
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 - ODP Intervertebral Fusion Device With Bone Graft, Cervical

All 312
Devices cleared under the same product code (ODP) and FDA review panel - the closest regulatory comparables to K141337.
NUVASIVE COROENT SMALL CONTOURED INTERBODY SYSTEM
K142050 · Nu Vasive, Incorporated · Oct 2014
SPINEFRONTIER ARENA-C HA PEEK CERVICAL INTERVERTEBRAL BODY FUSION DEVICE
K142026 · Spinefrontier, Inc. · Oct 2014
DIVERGENCE Anterior Cervical Fusion System
K142450 · Medtronic Sofamor Danek USA, Inc. · Oct 2014
FORTICORE
K140280 · Nanovis, LLC · Sep 2014
XENCO MEDICAL CERVICAL INTERBODY SYSTEM
K140786 · Xenco Medical, LLC · Sep 2014
EXACTECH CERVICAL SPACER SYSTEM
K141129 · Exactech, Inc. · Aug 2014