Cleared Traditional

FAVO S-TLIF

K190680 · Silony Medical GmbH · Orthopedic

Jul 2019

Decision

122d

Days

Class 2

Risk

About This 510(k) Submission

K190680 is an FDA 510(k) clearance for the FAVO S-TLIF, a Intervertebral Fusion Device With Bone Graft, Lumbar (Class II — Special Controls, product code MAX), submitted by Silony Medical GmbH (Leinfelden-Echterdingen, DE). The FDA issued a Cleared decision on July 18, 2019, 122 days after receiving the submission on March 18, 2019. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K190680 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 18, 2019
Decision Date	July 18, 2019
Days to Decision	122 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	MAX — Intervertebral Fusion Device With Bone Graft, Lumbar
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3080
Definition	Intended To Stabilize Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft.