FDA 510(k)

SU-POR 患者特异性颅骨植入物，SU-POR 患者特异性面部植入物

K号: K152463 · 2016-01-20

决定日期2016-01-20

产品代码FWP

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决定实质等同

器械摘要

SU-POR Patient-Specific Cranial Implant, SU-POR Patient-Specific Facial Implant is the device name listed in this FDA 510(k) record. The listed applicant is Poriferous, LLC. It received FDA 510(k) clearance on 2016-01-20 under 510(k) number K152463. The device is classified under product code FWP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the SU-POR Patient-Specific Cranial Implant, SU-POR Patient-Specific Facial Implant?

SU-POR Patient-Specific Cranial Implant, SU-POR Patient-Specific Facial Implant is a medical device that received FDA 510(k) clearance on 2016-01-20. The listed applicant is Poriferous, LLC. The 510(k) number is K152463.

When did SU-POR Patient-Specific Cranial Implant, SU-POR Patient-Specific Facial Implant receive FDA 510(k) clearance?

SU-POR Patient-Specific Cranial Implant, SU-POR Patient-Specific Facial Implant received FDA 510(k) clearance on 2016-01-20, under 510(k) number K152463.

Who is the listed applicant for SU-POR Patient-Specific Cranial Implant, SU-POR Patient-Specific Facial Implant?

The FDA 510(k) record lists Poriferous, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SU-POR Patient-Specific Cranial Implant, SU-POR Patient-Specific Facial Implant?

The FDA product code for SU-POR Patient-Specific Cranial Implant, SU-POR Patient-Specific Facial Implant is FWP.

官方来源

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SU-POR 患者特异性颅骨植入物，SU-POR 患者特异性面部植入物

器械摘要

常见问题

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