BIOCERAMIC ORBITAL IMPLANT, ORBTEX— 510(k) K110554

Name: FDA 510(k) clearance K110554
Creator: U.S. Food and Drug Administration
Published: 2011-11-02

Substantially Equivalent

Ceramisys, Ltd.

FDA 510(k) clearance K110554 for BIOCERAMIC ORBITAL IMPLANT, ORBTEX, Substantially Equivalent on 2011-11-02. Applicant: Ceramisys, Ltd.. Device class: 2.

Clearance details

Applicant: Ceramisys, Ltd.
Product code: Code HPZ
Device class: Class 2
Regulation: 21 CFR 886.3320
Advisory panel: Ophthalmic
Date received: 2011-02-28
Decision date: 2011-11-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Centercille, MA, US

Download summary PDF View on FDA.gov ↗

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