FDA 510(k)

SyntheCel Dura Repair

K号: K212943 · 2022-01-28

决定日期2022-01-28

产品代码GXQ

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决定实质等同

器械摘要

SyntheCel Dura Repair 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 2022-01-28 under 510(k) number K212943. The device is classified under product code GXQ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the SyntheCel Dura Repair?

SyntheCel Dura Repair is a medical device that received FDA 510(k) clearance on 2022-01-28. The listed applicant is Synthes (USA) Products, LLC. The 510(k) number is K212943.

When did SyntheCel Dura Repair receive FDA 510(k) clearance?

SyntheCel Dura Repair received FDA 510(k) clearance on 2022-01-28, under 510(k) number K212943.

Who is the listed applicant for SyntheCel Dura Repair?

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 SyntheCel Dura Repair?

The FDA product code for SyntheCel Dura Repair is GXQ.

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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