Cleared Traditional

K163474 - CAVUX CervicalCage-L SA System

K163474 is an FDA 510(k) clearance for CAVUX CervicalCage-L SA System, manufactured by Providence Medical Technology, Inc.. The device is a Class 2 Orthopedic device with product code OVE cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K163474 · Providence Medical Technology, Inc. · Orthopedic device
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Mar 2017
Decision
88d
Days
Class 2
Risk

K163474 is an FDA 510(k) clearance for the CAVUX CervicalCage-L SA System. Classified as Intervertebral Fusion Device With Integrated Fixation, Cervical (product code OVE), Class II - Special Controls.

Submitted by Providence Medical Technology, Inc. (Walnut Creek, US). The FDA issued a Cleared decision on March 10, 2017 after a review of 88 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 Providence Medical Technology, Inc. devices

FDA 510(k) Submission Details - K163474

510(k) Number K163474 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 2016
Decision Date March 10, 2017
Days to Decision 88 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
34d faster than avg
Panel avg: 122d · This submission: 88d
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 125
Devices cleared under the same product code (OVE) and FDA review panel - the closest regulatory comparables to K163474.
Paramount Anterior Cervical Cage System
K173175 · Spine Wave, Inc. · Nov 2017
SeaSpine Shoreline ACS - Anterior Cervical Standalone System
K170569 · SeaSpine Orthopedics Corporation · Jun 2017
NuVasive CoRoent Small Interlock II System
K170961 · Nu Vasive, Incorporated · Jun 2017
Spine Wave Anterior Cervical Spine System
K162760 · Spine Wave, Inc. · Feb 2017
Irix-C Cervical Integrated Fusion System
K162944 · X-Spine Systems, Inc. · Nov 2016
NuVasive® CoRoent® Small Interlock™ System
K161442 · Nu Vasive, Incorporated · Sep 2016