Cleared Traditional

Ti-Largo Cervical Interbody System

K223231 · Flospine · Orthopedic

Feb 2023

Decision

129d

Days

Class 2

Risk

About This 510(k) Submission

K223231 is an FDA 510(k) clearance for the Ti-Largo Cervical Interbody System, a Intervertebral Fusion Device With Bone Graft, Cervical (Class II — Special Controls, product code ODP), submitted by Flospine (Boca Raton, US). The FDA issued a Cleared decision on February 24, 2023, 129 days after receiving the submission on October 18, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K223231 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 18, 2022
Decision Date	February 24, 2023
Days to Decision	129 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.