Cleared Special

OsteoFab Patient Specific Facial Device

K161052 · Oxford Performance Materials, Inc. · General & Plastic Surgery

Jul 2016

Decision

97d

Days

Class 2

Risk

About This 510(k) Submission

K161052 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, Inc. (South Windsor, US). The FDA issued a Cleared decision on July 20, 2016, 97 days after receiving the submission on April 14, 2016. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.3500.

Submission Details

510(k) Number	K161052 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 14, 2016
Decision Date	July 20, 2016
Days to Decision	97 days
Submission Type	Special
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