Cleared Traditional

C-CURVE Interbody Fusion Device

K210470 · Medicrea International SA · Orthopedic

Sep 2021

Decision

198d

Days

Class 2

Risk

About This 510(k) Submission

K210470 is an FDA 510(k) clearance for the C-CURVE Interbody Fusion Device, a Intervertebral Fusion Device With Integrated Fixation, Cervical (Class II — Special Controls, product code OVE), submitted by Medicrea International SA (Rillieux-La-Pape, FR). The FDA issued a Cleared decision on September 3, 2021, 198 days after receiving the submission on February 17, 2021. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K210470 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 17, 2021
Decision Date	September 03, 2021
Days to Decision	198 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	OVE — Intervertebral Fusion Device With Integrated Fixation, 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 With Or Without Supplemental Fixation.