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 a medical device manufactured by Osteogenics Biomedical, Inc.. It received FDA 510(k) clearance on 2021-01-23 under approval 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. It is manufactured by Osteogenics Biomedical, Inc.. The 510(k) number is K201187.
When was Cytoplast Titanium-Reinforced PTFE Membranes approved by the FDA?
Cytoplast Titanium-Reinforced PTFE Membranes received FDA 510(k) clearance on 2021-01-23, under approval number K201187.
What company makes Cytoplast Titanium-Reinforced PTFE Membranes?
Cytoplast Titanium-Reinforced PTFE Membranes is manufactured by Osteogenics Biomedical, Inc..
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
Other Devices by Osteogenics Biomedical, Inc.
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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.