Cleared Traditional

SCARLET AC-T

K172065 · Spineart · Orthopedic

Sep 2017

Decision

84d

Days

Class 2

Risk

About This 510(k) Submission

K172065 is an FDA 510(k) clearance for the SCARLET AC-T, a Intervertebral Fusion Device With Bone Graft, Cervical (Class II — Special Controls, product code ODP), submitted by Spineart (Plan Les Ouates, CH). The FDA issued a Cleared decision on September 29, 2017, 84 days after receiving the submission on July 7, 2017. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K172065 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 07, 2017
Decision Date	September 29, 2017
Days to Decision	84 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.