Cleared Traditional

OSTEOFAB PATIENT SPECIFIC FACIAL DEVICE

K133809 · Oxford Performance Materials · General & Plastic Surgery

Jul 2014

Decision

224d

Days

Class 2

Risk

About This 510(k) Submission

K133809 is an FDA 510(k) clearance for the OSTEOFAB PATIENT SPECIFIC FACIAL DEVICE, a Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction (Class II — Special Controls, product code KKY), submitted by Oxford Performance Materials (South Windsor, US). The FDA issued a Cleared decision on July 28, 2014, 224 days after receiving the submission on December 16, 2013. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.3500.

Submission Details

510(k) Number	K133809 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 16, 2013
Decision Date	July 28, 2014
Days to Decision	224 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF

Device Classification

Product Code	KKY — Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 878.3500