FDA 510(k)

ReConnex Pre-Sutured Tendon

K号: K170957 · 2018-03-20

决定日期2018-03-20

产品代码GAT

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决定实质等同

器械摘要

ReConnex Pre-Sutured Tendon is the device name listed in this FDA 510(k) record. The listed applicant is Allosource. It received FDA 510(k) clearance on 2018-03-20 under 510(k) number K170957. The device is classified under product code GAT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the ReConnex Pre-Sutured Tendon?

ReConnex Pre-Sutured Tendon is a medical device that received FDA 510(k) clearance on 2018-03-20. The listed applicant is Allosource. The 510(k) number is K170957.

When did ReConnex Pre-Sutured Tendon receive FDA 510(k) clearance?

ReConnex Pre-Sutured Tendon received FDA 510(k) clearance on 2018-03-20, under 510(k) number K170957.

Who is the listed applicant for ReConnex Pre-Sutured Tendon?

The FDA 510(k) record lists Allosource as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ReConnex Pre-Sutured Tendon?

The FDA product code for ReConnex Pre-Sutured Tendon is GAT.

列明Allosource为申报人的其他记录

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