Cleared Traditional

K160066 - Pro-Link Stand-Alone Cervical Spacer Sy...

K160066 is the FDA 510(k) clearance for Pro-Link Stand-Alone Cervical Spacer Sy... by Life Spine, Inc.. It is a Class 2 Orthopedic device (product code OVE) cleared through the Traditional 510(k) pathway after a 233-day FDA review.

K160066 · Life Spine, Inc. · Orthopedic device
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Sep 2016
Decision
233d
Days
Class 2
Risk

K160066 is an FDA 510(k) clearance for the Pro-Link® Stand-Alone 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 September 2, 2016 after a review of 233 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 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 K160066 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 13, 2016
Decision Date September 02, 2016
Days to Decision 233 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
111d slower than avg
Panel avg: 122d · This submission: 233d
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 115
Devices cleared under the same product code (OVE) and FDA review panel - the closest regulatory comparables to K160066.
Irix-C Cervical Integrated Fusion System
K162944 · X-Spine Systems, Inc. · Nov 2016
NuVasive® CoRoent® Small Interlock™ System
K161442 · Nu Vasive, Incorporated · Sep 2016
SeaSpine Shoreline ACS - Anterior Cervical Standalone System
K161081 · SeaSpine Orthopedics Corporation · Sep 2016
Vertu® & Vertu® Ti-Bond and Crystal® & Crystal® Ti-Bond Cervical Interbody System
K153352 · Spinal Elements, Inc. · Aug 2016
Genesys Spine Apache® Anchored Cervical Interbody Fusion System
K152099 · Genesys Spine · Jul 2016
Cervical Stand Alone System
K161280 · Orthofix, Inc. · Jun 2016