FDA 510(k)

Integrity-SI TM Fusion System

K-번호: K161755 · 2016-12-14

결정일2016-12-14

제품 코드OUR

자문 위원회OR

결정Substantially Equivalent

기기 요약

Integrity-SI TM Fusion System is the device name listed in this FDA 510(k) record. The listed applicant is Coorstek Medical. It received FDA 510(k) clearance on 2016-12-14 under 510(k) number K161755. The device is classified under product code OUR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Integrity-SI TM Fusion System?

Integrity-SI TM Fusion System is a medical device that received FDA 510(k) clearance on 2016-12-14. The listed applicant is Coorstek Medical. The 510(k) number is K161755.

When did Integrity-SI TM Fusion System receive FDA 510(k) clearance?

Integrity-SI TM Fusion System received FDA 510(k) clearance on 2016-12-14, under 510(k) number K161755.

Who is the listed applicant for Integrity-SI TM Fusion System?

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

What is the FDA product code for Integrity-SI TM Fusion System?

The FDA product code for Integrity-SI TM Fusion System is OUR.

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Integrity-SI TM Fusion System

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: OUR)

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