Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

RPM Reinforced PTFE Mesh

K-Number: K171774 · 2017-10-19

ApplicantOsteogenics Biomedical, Inc.
Decision Date2017-10-19
Product CodeNPK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

RPM Reinforced PTFE Mesh 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 2017-10-19 under 510(k) number K171774. 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 RPM Reinforced PTFE Mesh?

RPM Reinforced PTFE Mesh is a medical device that received FDA 510(k) clearance on 2017-10-19. The listed applicant is Osteogenics Biomedical, Inc.. The 510(k) number is K171774.

When did RPM Reinforced PTFE Mesh receive FDA 510(k) clearance?

RPM Reinforced PTFE Mesh received FDA 510(k) clearance on 2017-10-19, under 510(k) number K171774.

Who is the listed applicant for RPM Reinforced PTFE Mesh?

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 RPM Reinforced PTFE Mesh?

The FDA product code for RPM Reinforced PTFE Mesh 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.

K201187Cytoplast Titanium-Reinforced PTFE Membranes

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.K201187Cytoplast Titanium-Reinforced PTFE MembranesOsteogenics Biomedical, Inc.K160493Cytosurg non-resorbable PTFE Membrane, 25mm x 30mm, Cytosurg non-resorbable PTFE Membrane, 12mm x 24mmSalvin Dental Specialties

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.

↑