Cleared Traditional

K180215 - DYNA-LINK ELITE Stand-Alone Anterior Lu...

K180215 is the FDA 510(k) clearance for DYNA-LINK ELITE Stand-Alone Anterior Lu... by Life Spine, Inc.. It is a Class 2 Orthopedic device (product code OVD) cleared through the Traditional 510(k) pathway after a 231-day FDA review.

K180215 · Life Spine, Inc. · Orthopedic device
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Sep 2018
Decision
231d
Days
Class 2
Risk

K180215 is an FDA 510(k) clearance for the DYNA-LINK ELITE Stand-Alone Anterior Lumbar System. Classified as Intervertebral Fusion Device With Integrated Fixation, Lumbar (product code OVD), Class II - Special Controls.

Submitted by Life Spine, Inc. (Huntley, US). The FDA issued a Cleared decision on September 13, 2018 after a review of 231 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 K180215 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 2018
Decision Date September 13, 2018
Days to Decision 231 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
109d slower than avg
Panel avg: 122d · This submission: 231d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3080
Definition Intended To Stabilize Lumbar 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 - OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar

All 147
Devices cleared under the same product code (OVD) and FDA review panel - the closest regulatory comparables to K180215.
Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) System
K182007 · Renovis Surgical Technologies · Dec 2018
Arco™-SA Lumbar Cage System
K182195 · Neurostructures, Inc. · Nov 2018
Scarlet AL-T
K181818 · Spineart · Oct 2018
NuVasive Brigade Lateral System
K181386 · Nu Vasive, Incorporated · Aug 2018
CoreLink® M3™ Stand-Alone Anterior Lumbar System
K180814 · Corelink, LLC · Aug 2018
FBC 921 (ALIF)
K180695 · Fbc Device Aps · Jul 2018