INDEPENDENCE MIS Spacers
K号: K160597 · 2016-08-29
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器械摘要
INDEPENDENCE MIS Spacers is the device name listed in this FDA 510(k) record. The listed applicant is Globus Medical, Inc.. It received FDA 510(k) clearance on 2016-08-29 under 510(k) number K160597. 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 INDEPENDENCE MIS Spacers?
INDEPENDENCE MIS Spacers is a medical device that received FDA 510(k) clearance on 2016-08-29. The listed applicant is Globus Medical, Inc.. The 510(k) number is K160597.
When did INDEPENDENCE MIS Spacers receive FDA 510(k) clearance?
INDEPENDENCE MIS Spacers received FDA 510(k) clearance on 2016-08-29, under 510(k) number K160597.
Who is the listed applicant for INDEPENDENCE MIS Spacers?
The FDA 510(k) record lists Globus Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for INDEPENDENCE MIS Spacers?
The FDA product code for INDEPENDENCE MIS Spacers is OVD.
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相关器械（代码：OVD）
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官方来源
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