Cleared Traditional

MectaLIF Anterior Stand-Alone

K160605 · Medacta International · Orthopedic

Jul 2016

Decision

141d

Days

Class 2

Risk

About This 510(k) Submission

K160605 is an FDA 510(k) clearance for the MectaLIF Anterior Stand-Alone, a Intervertebral Fusion Device With Integrated Fixation, Lumbar (Class II — Special Controls, product code OVD), submitted by Medacta International (Castel San Pietro, CH). The FDA issued a Cleared decision on July 21, 2016, 141 days after receiving the submission on March 2, 2016. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K160605 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 02, 2016
Decision Date	July 21, 2016
Days to Decision	141 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	OVD — Intervertebral Fusion Device With Integrated Fixation, Lumbar
Device Class	Class II — 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.