Cleared Traditional

K181717 - Life Spine Laminoplasty System

K181717 is an FDA 510(k) clearance for Life Spine Laminoplasty System, manufactured by Life Spine, Inc.. The device is a Class 2 Orthopedic device with product code NQW cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K181717 · Life Spine, Inc. · Orthopedic device
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Oct 2018
Decision
106d
Days
Class 2
Risk

K181717 is an FDA 510(k) clearance for the Life Spine Laminoplasty System. Classified as Orthosis, Spine, Plate, Laminoplasty, Metal (product code NQW), Class II - Special Controls.

Submitted by Life Spine, Inc. (Huntley, US). The FDA issued a Cleared decision on October 12, 2018 after a review of 106 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3050 - 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

FDA 510(k) Submission Details - K181717

510(k) Number K181717 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 2018
Decision Date October 12, 2018
Days to Decision 106 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
16d faster than avg
Panel avg: 122d · This submission: 106d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NQW Device Classification - Class 2, Special Controls

Product Code NQW Orthosis, Spine, Plate, Laminoplasty, Metal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3050
Definition This Device Is A Plate That Is Attached To The Lamina After A Laminoplasty Or Laminectomy Procedure.
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 - NQW Orthosis, Spine, Plate, Laminoplasty, Metal

All 28
Devices cleared under the same product code (NQW) and FDA review panel - the closest regulatory comparables to K181717.
Centerpiece Plate Fixation System
K212428 · Medtronic Sofamor Danek · Dec 2021
Hinged Laminoplasty System
K191927 · Life Spine, Inc. · Sep 2019
NuVasive® Camber Laminoplasty System
K191169 · Nu Vasive, Incorporated · Jul 2019
Choice Spine Laminoplasty™ Fixation System
K173215 · Choicespine, LP · Jan 2018
HAVEN™ Laminoplasty System, CANOPY® Laminoplasty Fixation System
K171413 · Globus Medical, Inc. · Jul 2017
Xspan Laminoplasty Fixation System
K160114 · X-Spine Systems, Inc. · Mar 2016