Cleared Traditional

K162760 - Spine Wave Anterior Cervical Spine System

K162760 is an FDA 510(k) clearance for Spine Wave Anterior Cervical Spine System, manufactured by Spine Wave, Inc.. The device is a Class 2 Orthopedic device with product code OVE cleared through the Traditional 510(k) pathway after a 139-day FDA review.

K162760 · Spine Wave, Inc. · Orthopedic device
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Feb 2017
Decision
139d
Days
Class 2
Risk

K162760 is an FDA 510(k) clearance for the Spine Wave Anterior Cervical Spine System. Classified as Intervertebral Fusion Device With Integrated Fixation, Cervical (product code OVE), Class II - Special Controls.

Submitted by Spine Wave, Inc. (Shelton, US). The FDA issued a Cleared decision on February 16, 2017 after a review of 139 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 Spine Wave, Inc. devices

FDA 510(k) Submission Details - K162760

510(k) Number K162760 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2016
Decision Date February 16, 2017
Days to Decision 139 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
17d slower than avg
Panel avg: 122d · This submission: 139d
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 162
Devices cleared under the same product code (OVE) and FDA review panel - the closest regulatory comparables to K162760.
NuVasive CoRoent Small Interlock II System
K170961 · Nu Vasive, Incorporated · Jun 2017
Tomcat Cervical Spinal System
K170953 · Choicespine, LP · Apr 2017
CAVUX CervicalCage-L SA System
K163474 · Providence Medical Technology, Inc. · Mar 2017
STERISPINE CC
K162531 · Safe Orthopaedics · Dec 2016
Irix-C Cervical Integrated Fusion System
K162944 · X-Spine Systems, Inc. · Nov 2016
Xenco Medical Cervical Interbody System
K160313 · Xenco Medical, LLC · Oct 2016