FDA 510(k)

XO1 Knee Balancing System

K-번호: K162237 · 2017-04-25

결정일2017-04-25

제품 코드ONN

자문 위원회NE

결정Substantially Equivalent

기기 요약

XO1 Knee Balancing System is the device name listed in this FDA 510(k) record. The listed applicant is Xpandortho, Inc.. It received FDA 510(k) clearance on 2017-04-25 under 510(k) number K162237. The device is classified under product code ONN. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the XO1 Knee Balancing System?

XO1 Knee Balancing System is a medical device that received FDA 510(k) clearance on 2017-04-25. The listed applicant is Xpandortho, Inc.. The 510(k) number is K162237.

When did XO1 Knee Balancing System receive FDA 510(k) clearance?

XO1 Knee Balancing System received FDA 510(k) clearance on 2017-04-25, under 510(k) number K162237.

Who is the listed applicant for XO1 Knee Balancing System?

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

What is the FDA product code for XO1 Knee Balancing System?

The FDA product code for XO1 Knee Balancing System is ONN.

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XO1 Knee Balancing System

기기 요약

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관련 임상시험

관련 기기 (코드: ONN)

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