Cleared Traditional

uCerv Flux-C 3D Porous Titanium Cervical Interbody

K220696 · Ulrich Medical USA · Orthopedic

Aug 2022

Decision

163d

Days

Class 2

Risk

About This 510(k) Submission

K220696 is an FDA 510(k) clearance for the uCerv Flux-C 3D Porous Titanium Cervical Interbody, a Intervertebral Fusion Device With Bone Graft, Cervical (Class II — Special Controls, product code ODP), submitted by Ulrich Medical USA (Chesterfield, US). The FDA issued a Cleared decision on August 19, 2022, 163 days after receiving the submission on March 9, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K220696 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 09, 2022
Decision Date	August 19, 2022
Days to Decision	163 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.