FDA 510(k)

EZ-TRAX Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Device

K-번호: K213209 · 2021-12-28

결정일2021-12-28

제품 코드KCT

자문 위원회HO

결정Substantially Equivalent

기기 요약

EZ-TRAX Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Device is the device name listed in this FDA 510(k) record. The listed applicant is K1 Medical, LLC. It received FDA 510(k) clearance on 2021-12-28 under 510(k) number K213209. The device is classified under product code KCT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the EZ-TRAX Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Device?

EZ-TRAX Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Device is a medical device that received FDA 510(k) clearance on 2021-12-28. The listed applicant is K1 Medical, LLC. The 510(k) number is K213209.

When did EZ-TRAX Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Device receive FDA 510(k) clearance?

EZ-TRAX Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Device received FDA 510(k) clearance on 2021-12-28, under 510(k) number K213209.

Who is the listed applicant for EZ-TRAX Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Device?

The FDA 510(k) record lists K1 Medical, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EZ-TRAX Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Device?

The FDA product code for EZ-TRAX Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Device is KCT.

K1 Medical, LLC를 신청인으로 등재한 기타 기록

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