FDA 510(k)PILLAR SA PTC
K号: K161129 · 2016-09-08
决定日期2016-09-08
产品代码OVD
咨询委员会OR
决定Substantially Equivalent
器械摘要
PILLAR SA PTC is the device name listed in this FDA 510(k) record. The listed applicant is Orthofix, Inc.. It received FDA 510(k) clearance on 2016-09-08 under 510(k) number K161129. The device is classified under product code OVD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the PILLAR SA PTC?
PILLAR SA PTC is a medical device that received FDA 510(k) clearance on 2016-09-08. The listed applicant is Orthofix, Inc.. The 510(k) number is K161129.
When did PILLAR SA PTC receive FDA 510(k) clearance?
PILLAR SA PTC received FDA 510(k) clearance on 2016-09-08, under 510(k) number K161129.
Who is the listed applicant for PILLAR SA PTC?
The FDA 510(k) record lists Orthofix, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for PILLAR SA PTC?
The FDA product code for PILLAR SA PTC is OVD.
相关临床试验
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列明Orthofix, Inc.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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相关器械(代码:OVD)
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。