Cleared Traditional

Fortilink?-C with TETRAfuse? 3D Technology

K163673 · Rti Surgical, Inc. · Orthopedic

May 2017

Decision

147d

Days

Class 2

Risk

About This 510(k) Submission

K163673 is an FDA 510(k) clearance for the Fortilink?-C with TETRAfuse? 3D Technology, a Intervertebral Fusion Device With Bone Graft, Cervical (Class II — Special Controls, product code ODP), submitted by Rti Surgical, Inc. (Alachua, US). The FDA issued a Cleared decision on May 23, 2017, 147 days after receiving the submission on December 27, 2016. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K163673 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 27, 2016
Decision Date	May 23, 2017
Days to Decision	147 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

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