Lumina-PTFE 钛合金
K号: K221851 · 2023-12-08
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决定日期2023-12-08
产品代码NPK
咨询委员会DE
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决定实质等同
器械摘要
Lumina-PTFE Titanium is the device name listed in this FDA 510(k) record. The listed applicant is Criteria Industria E Comercio DE Produtos Medicinais. It received FDA 510(k) clearance on 2023-12-08 under 510(k) number K221851. The device is classified under product code NPK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Lumina-PTFE Titanium?
Lumina-PTFE Titanium is a medical device that received FDA 510(k) clearance on 2023-12-08. The listed applicant is Criteria Industria E Comercio DE Produtos Medicinais. The 510(k) number is K221851.
When did Lumina-PTFE Titanium receive FDA 510(k) clearance?
Lumina-PTFE Titanium received FDA 510(k) clearance on 2023-12-08, under 510(k) number K221851.
Who is the listed applicant for Lumina-PTFE Titanium?
The FDA 510(k) record lists Criteria Industria E Comercio DE Produtos Medicinais as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Lumina-PTFE Titanium?
The FDA product code for Lumina-PTFE Titanium is NPK.
相关临床试验
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
相关器械（代码：NPK）
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
K222549OpenTexPurgo Biologics, Inc.K211554InnoGenic 不吸收性膜Cowellmedi Co., Ltd.K210797Bio-MEM Ti 强化膜B&Medi Co., Ltd.K201187Cytoplast钛增强PTFE膜Osteogenics Biomedical, Inc.K171774RPM 加强型 PTFE 网格Osteogenics Biomedical, Inc.K160493Cytosurg不可吸收PTFE膜，25mm x 30mm，Cytosurg不可吸收PTFE膜，12mm x 24mmSalvin Dental Specialties
官方来源
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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