FDA 510(k)

OsteoMed PINNACLE 驱动器

K号: K162544 · 2017-04-04

决定日期2017-04-04

产品代码KMW

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决定实质等同

器械摘要

OsteoMed PINNACLE Driver is the device name listed in this FDA 510(k) record. The listed applicant is Osteomed. It received FDA 510(k) clearance on 2017-04-04 under 510(k) number K162544. The device is classified under product code KMW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the OsteoMed PINNACLE Driver?

OsteoMed PINNACLE Driver is a medical device that received FDA 510(k) clearance on 2017-04-04. The listed applicant is Osteomed. The 510(k) number is K162544.

When did OsteoMed PINNACLE Driver receive FDA 510(k) clearance?

OsteoMed PINNACLE Driver received FDA 510(k) clearance on 2017-04-04, under 510(k) number K162544.

Who is the listed applicant for OsteoMed PINNACLE Driver?

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

What is the FDA product code for OsteoMed PINNACLE Driver?

The FDA product code for OsteoMed PINNACLE Driver is KMW.

列明Osteomed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。

K203479ExtremiLOCK Lateral Ankle Fusion Plates K162542OsteoMed PINNACLE 驱动器 K161041OsteoMed ExtremiLOCK 腕骨板系统

官方来源

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数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。