Cleared Traditional

Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D Technology

K192718 · Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) · Orthopedic

Dec 2019

Decision

84d

Days

Class 2

Risk

About This 510(k) Submission

K192718 is an FDA 510(k) clearance for the Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D Technology, a Intervertebral Fusion Device With Bone Graft, Lumbar (Class II — Special Controls, product code MAX), submitted by Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) (Marquette, US). The FDA issued a Cleared decision on December 20, 2019, 84 days after receiving the submission on September 27, 2019. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K192718 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 27, 2019
Decision Date	December 20, 2019
Days to Decision	84 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.