Cleared Traditional

K231704 - Pro-Link & Pro-Link Ti Barbs Cervical S...

K231704 is the FDA 510(k) clearance for Pro-Link & Pro-Link Ti Barbs Cervical S... by Life Spine, Inc.. It is a Class 2 Orthopedic device (product code OVE) cleared through the Traditional 510(k) pathway after a 129-day FDA review.

K231704 · Life Spine, Inc. · Orthopedic device
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Oct 2023
Decision
129d
Days
Class 2
Risk

K231704 is an FDA 510(k) clearance for the Pro-Link® & Pro-Link® Ti Barbs Cervical Spacer System. Classified as Intervertebral Fusion Device With Integrated Fixation, Cervical (product code OVE), Class II - Special Controls.

Submitted by Life Spine, Inc. (Huntley, US). The FDA issued a Cleared decision on October 19, 2023 after a review of 129 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 Life Spine, Inc. devices

Submission Details

510(k) Number K231704 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 2023
Decision Date October 19, 2023
Days to Decision 129 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
7d slower than avg
Panel avg: 122d · This submission: 129d
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 114
Devices cleared under the same product code (OVE) and FDA review panel - the closest regulatory comparables to K231704.
Shoreline ACS Interbody System
K233414 · SeaSpine Orthopedics Corporation · Nov 2023
TotalTi ACDF by SAGICO
K233191 · Spinal Analytics & Geometrical Implant Co, LLC · Nov 2023
RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion System
K232348 · MiRus, LLC · Oct 2023
Cervical Spine Truss System (CSTS)
K231739 · 4Web Medical, Inc. · Sep 2023
ChoiceSpine Blackhawk Ti Cervical Spacer System
K223869 · Choice Spine, LLC · Sep 2023
Stable-C Interbody System
K231763 · Nexus Spine, LLC · Aug 2023