OsteoFab Patient Specific Facial Device— 510(k) K161052

Name: FDA 510(k) clearance K161052
Creator: U.S. Food and Drug Administration
Published: 2016-07-20

Substantially Equivalent

Oxford Performance Materials, Inc.

FDA 510(k) clearance K161052 for OsteoFab Patient Specific Facial Device, Substantially Equivalent on 2016-07-20. Applicant: Oxford Performance Materials, Inc.. Device class: 2.

Clearance details

Applicant: Oxford Performance Materials, Inc.
Product code: Code KKY
Device class: Class 2
Regulation: 21 CFR 878.3500
Advisory panel: General, Plastic Surgery
Date received: 2016-04-14
Decision date: 2016-07-20
Decision: Substantially Equivalent
Clearance type: Special
Location: South Windsor, CT, US

Download summary PDF View on FDA.gov ↗

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