FDA 510(k)

DePuy Synthes 多孔聚乙烯植入物和钛丝产品组合 - MR 条件

K号: K183472 · 2019-03-13

决定日期2019-03-13

产品代码FTM

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决定实质等同

器械摘要

DePuy Synthes Porous Polyethylene Implants and Titanium Wires Portfolio – MR Conditional is the device name listed in this FDA 510(k) record. The listed applicant is Synthes (USA) Products, LLC. It received FDA 510(k) clearance on 2019-03-13 under 510(k) number K183472. The device is classified under product code FTM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the DePuy Synthes Porous Polyethylene Implants and Titanium Wires Portfolio – MR Conditional?

DePuy Synthes Porous Polyethylene Implants and Titanium Wires Portfolio – MR Conditional is a medical device that received FDA 510(k) clearance on 2019-03-13. The listed applicant is Synthes (USA) Products, LLC. The 510(k) number is K183472.

When did DePuy Synthes Porous Polyethylene Implants and Titanium Wires Portfolio – MR Conditional receive FDA 510(k) clearance?

DePuy Synthes Porous Polyethylene Implants and Titanium Wires Portfolio – MR Conditional received FDA 510(k) clearance on 2019-03-13, under 510(k) number K183472.

Who is the listed applicant for DePuy Synthes Porous Polyethylene Implants and Titanium Wires Portfolio – MR Conditional?

The FDA 510(k) record lists Synthes (USA) Products, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DePuy Synthes Porous Polyethylene Implants and Titanium Wires Portfolio – MR Conditional?

The FDA product code for DePuy Synthes Porous Polyethylene Implants and Titanium Wires Portfolio – MR Conditional is FTM.

列明Synthes (USA) Products, LLC为申报人的其他记录

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。

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