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FDA 510(k)

Cytoplast Titanium-Reinforced PTFE Membranes

K-Number: K201187 · 2021-01-23

ApplicantOsteogenics Biomedical, Inc.
Decision Date2021-01-23
Product CodeNPK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Cytoplast Titanium-Reinforced PTFE Membranes is the device name listed in this FDA 510(k) record. The listed applicant is Osteogenics Biomedical, Inc.. It received FDA 510(k) clearance on 2021-01-23 under 510(k) number K201187. The device is classified under product code NPK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Cytoplast Titanium-Reinforced PTFE Membranes?

Cytoplast Titanium-Reinforced PTFE Membranes is a medical device that received FDA 510(k) clearance on 2021-01-23. The listed applicant is Osteogenics Biomedical, Inc.. The 510(k) number is K201187.

When did Cytoplast Titanium-Reinforced PTFE Membranes receive FDA 510(k) clearance?

Cytoplast Titanium-Reinforced PTFE Membranes received FDA 510(k) clearance on 2021-01-23, under 510(k) number K201187.

Who is the listed applicant for Cytoplast Titanium-Reinforced PTFE Membranes?

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

What is the FDA product code for Cytoplast Titanium-Reinforced PTFE Membranes?

The FDA product code for Cytoplast Titanium-Reinforced PTFE Membranes is NPK.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07520903Titanium-Reinforced PTFE Membranes for Bone AugmentationCOMPLETED

Other records listing Osteogenics Biomedical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K171774RPM Reinforced PTFE Mesh

Related Devices (Code: NPK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K221851Lumina-PTFE TitaniumCriteria Industria E Comercio DE Produtos MedicinaisK222549OpenTexPurgo Biologics, Inc.K211554InnoGenic Non-resorbable MembraneCowellmedi Co., Ltd.K210797Bio-MEM Ti Reinforced MembraneB&Medi Co., Ltd.K171774RPM Reinforced PTFE MeshOsteogenics Biomedical, Inc.K160493Cytosurg non-resorbable PTFE Membrane, 25mm x 30mm, Cytosurg non-resorbable PTFE Membrane, 12mm x 24mmSalvin Dental Specialties

Official Source

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

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