Cleared Traditional

Hinged Laminoplasty System

K191927 · Life Spine, Inc. · Orthopedic

Sep 2019

Decision

63d

Days

Class 2

Risk

About This 510(k) Submission

K191927 is an FDA 510(k) clearance for the Hinged Laminoplasty System, a Orthosis, Spine, Plate, Laminoplasty, Metal (Class II — Special Controls, product code NQW), submitted by Life Spine, Inc. (Huntley, US). The FDA issued a Cleared decision on September 20, 2019, 63 days after receiving the submission on July 19, 2019. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3050.

Submission Details

510(k) Number	K191927 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 19, 2019
Decision Date	September 20, 2019
Days to Decision	63 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	NQW — Orthosis, Spine, Plate, Laminoplasty, Metal
Device Class	Class II — 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.