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FDA 510(k)

SU-POR Patient-Specific Cranial Implant, SU-POR Patient-Specific Facial Implant

K-Number: K152463 · 2016-01-20

ApplicantPoriferous, LLC
Decision Date2016-01-20
Product CodeFWP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

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. It is manufactured by Poriferous, LLC. The 510(k) number is K152463.

When was SU-POR Patient-Specific Cranial Implant, SU-POR Patient-Specific Facial Implant approved by the FDA?

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

What company makes 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 manufactured by Poriferous, LLC.

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.

Related Clinical Trials

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Related PubMed Literature

PMID: 42181028 Systematic biocompatibility assessment of 4-µm surface silicone implants. Biomaterials and biosystems (2026) PMID: 42014629 Clinical implementation of an EU MDR-compliant point-of-care manufacturing framework for patient-specific 3D-printed PEEK implants in craniomaxillofacial reconstruction. 3D printing in medicine (2026) PMID: 41839575 A Perspective for Integrating Real-World Evidence Into the Investigational Device Exemption Study Design for Lumbar Total Joint Replacement. International journal of spine surgery (2026) PMID: 41770469 Use and regulation of patient-specific three-dimensional printing in medicine: a survey of physician end-users. 3D printing in medicine (2026)

Related Devices (Code: FWP)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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