FDA 510(k)

Premia Spine XL 仪器

K号: K191854 · 2019-10-08

决定日期2019-10-08

产品代码OLO

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决定实质等同

器械摘要

Premia Spine XL Instruments is the device name listed in this FDA 510(k) record. The listed applicant is Premia Spine, Ltd.. It received FDA 510(k) clearance on 2019-10-08 under 510(k) number K191854. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Premia Spine XL Instruments?

Premia Spine XL Instruments is a medical device that received FDA 510(k) clearance on 2019-10-08. The listed applicant is Premia Spine, Ltd.. The 510(k) number is K191854.

When did Premia Spine XL Instruments receive FDA 510(k) clearance?

Premia Spine XL Instruments received FDA 510(k) clearance on 2019-10-08, under 510(k) number K191854.

Who is the listed applicant for Premia Spine XL Instruments?

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

What is the FDA product code for Premia Spine XL Instruments?

The FDA product code for Premia Spine XL Instruments is OLO.

列明Premia Spine, 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。

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