FDA 510(k)

Striate+™

K号: K201241 · 2021-01-11

决定日期2021-01-11

产品代码NPL

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决定实质等同

器械摘要

Striate+™ is the device name listed in this FDA 510(k) record. The listed applicant is Orthocell, Ltd.. It received FDA 510(k) clearance on 2021-01-11 under 510(k) number K201241. The device is classified under product code NPL. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Striate+™?

Striate+™ is a medical device that received FDA 510(k) clearance on 2021-01-11. The listed applicant is Orthocell, Ltd.. The 510(k) number is K201241.

When did Striate+™ receive FDA 510(k) clearance?

Striate+™ received FDA 510(k) clearance on 2021-01-11, under 510(k) number K201241.

Who is the listed applicant for Striate+™?

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

What is the FDA product code for Striate+™?

The FDA product code for Striate+™ is NPL.

列明Orthocell, Ltd.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。

K243889Remplir (ON-152, 15 x 20 mm); Remplir (ON-203, 20 x 30 mm); Remplir (ON-304, 30 x 40 mm); Remplir (ON-405, 40 x 50 mm)

相关器械（代码：NPL）

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。

K242817Jason 膜Botiss Biomaterials GmbH K250512增强牙龈基质Neo Modulus (Suzhou) Medical Sci-Tech Co., Ltd.K252253Geistlich Mucograft® /Geistlich Mucograft® Seal; Geistlich Fibro-Gide®Geistlich Pharma AG K251062Geistlich Bio-Gide; Geistlich Bio-Gide® Shape; Geistlich Bio-Gide® Compressed; Geistlich Bio-Gide® Forte; Geistlich Bio-Gide® Perio; Geistlich Combi-Kit Collagen®; Geistlich Perio-System Combi PackGeistlich Pharma AG K250833SwissMembrane X；SwissMembrane X 插座Geistlich Pharma AG K233203软组织增强可吸收基质Collagen Matrix, Inc.

官方来源

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