Cleared Traditional

Fortilink? Interbody Fusion (IBF) System with TETRAfuse? 3D Technology

K172343 · Rti Surgical, Inc. · Orthopedic

Oct 2017

Decision

82d

Days

Class 2

Risk

About This 510(k) Submission

K172343 is an FDA 510(k) clearance for the Fortilink? Interbody Fusion (IBF) System with TETRAfuse? 3D Technology, a Intervertebral Fusion Device With Bone Graft, Lumbar (Class II — Special Controls, product code MAX), submitted by Rti Surgical, Inc. (Alachua, US). The FDA issued a Cleared decision on October 23, 2017, 82 days after receiving the submission on August 2, 2017. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K172343 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 02, 2017
Decision Date	October 23, 2017
Days to Decision	82 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.