Cleared Traditional

Fortilink? IBF System with TETRAfuse?3D Technology, include the following designs: Fortilink?-TS IBF System, Fortilink?-L I BF System, Fortilink?-C IBF System

K190498 · Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) · Orthopedic

Jul 2019

Decision

127d

Days

Class 2

Risk

About This 510(k) Submission

K190498 is an FDA 510(k) clearance for the Fortilink? IBF System with TETRAfuse?3D Technology, include the following designs: Fortilink?-TS IBF System, Fortilink?-L I BF System, Fortilink?-C IBF System, 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.) (Alachua, US). The FDA issued a Cleared decision on July 5, 2019, 127 days after receiving the submission on February 28, 2019. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K190498 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 28, 2019
Decision Date	July 05, 2019
Days to Decision	127 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.