PoreStar Patient Specific Implant— 510(k) K171037

Name: FDA 510(k) clearance K171037
Creator: U.S. Food and Drug Administration
Published: 2017-12-27

Substantially Equivalent

Anatomics Pty, Ltd.

FDA 510(k) clearance K171037 for PoreStar Patient Specific Implant, Substantially Equivalent on 2017-12-27. Applicant: Anatomics Pty, Ltd.. Device class: 2.

Clearance details

Applicant: Anatomics Pty, Ltd.
Product code: Code JOF
Device class: Class 2
Regulation: 21 CFR 874.3620
Advisory panel: Ear, Nose, Throat
Date received: 2017-04-06
Decision date: 2017-12-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St Kilda, AU

Download summary PDF View on FDA.gov ↗

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