Cleared Traditional

Mecta-C TiPEEK

K142744 · Medacta International · Orthopedic

May 2015

Decision

225d

Days

Class 2

Risk

About This 510(k) Submission

K142744 is an FDA 510(k) clearance for the Mecta-C TiPEEK, a Intervertebral Fusion Device With Bone Graft, Cervical (Class II — Special Controls, product code ODP), submitted by Medacta International (Castel San Pietro, CH). The FDA issued a Cleared decision on May 7, 2015, 225 days after receiving the submission on September 24, 2014. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K142744 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 24, 2014
Decision Date	May 07, 2015
Days to Decision	225 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.