SU-POR Patient-Specific Cranial Implant, SU-POR Patient-Specific Facial Implant— 510(k) K152463

Name: FDA 510(k) clearance K152463
Creator: U.S. Food and Drug Administration
Published: 2016-01-20

Substantially Equivalent

Poriferous, LLC

FDA 510(k) clearance K152463 for SU-POR Patient-Specific Cranial Implant, SU-POR Patient-Specific Facial Implant, Substantially Equivalent on 2016-01-20. Applicant: Poriferous, LLC. Device class: 2.

Clearance details

Applicant: Poriferous, LLC
Product code: Code FWP
Device class: Class 2
Regulation: 21 CFR 878.3550
Advisory panel: General, Plastic Surgery
Date received: 2015-08-28
Decision date: 2016-01-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Newnan, GA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.