FDA 510(k)

Alloclassic Zweymuller SL 대퇴골 끝, Alloclassic Zweymuller SL 기울기 대퇴골 끝

K-번호: K193050 · 2019-12-26

결정일2019-12-26

제품 코드LZO

자문 위원회OR

결정Substantially Equivalent

기기 요약

Alloclassic Zweymuller SL Femoral Stem, Alloclassic Zweymuller SL Offset Femoral Stem is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer GmbH. It received FDA 510(k) clearance on 2019-12-26 under 510(k) number K193050. The device is classified under product code LZO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Alloclassic Zweymuller SL Femoral Stem, Alloclassic Zweymuller SL Offset Femoral Stem?

Alloclassic Zweymuller SL Femoral Stem, Alloclassic Zweymuller SL Offset Femoral Stem is a medical device that received FDA 510(k) clearance on 2019-12-26. The listed applicant is Zimmer GmbH. The 510(k) number is K193050.

When did Alloclassic Zweymuller SL Femoral Stem, Alloclassic Zweymuller SL Offset Femoral Stem receive FDA 510(k) clearance?

Alloclassic Zweymuller SL Femoral Stem, Alloclassic Zweymuller SL Offset Femoral Stem received FDA 510(k) clearance on 2019-12-26, under 510(k) number K193050.

Who is the listed applicant for Alloclassic Zweymuller SL Femoral Stem, Alloclassic Zweymuller SL Offset Femoral Stem?

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

What is the FDA product code for Alloclassic Zweymuller SL Femoral Stem, Alloclassic Zweymuller SL Offset Femoral Stem?

The FDA product code for Alloclassic Zweymuller SL Femoral Stem, Alloclassic Zweymuller SL Offset Femoral Stem is LZO.

Zimmer GmbH를 신청인으로 등재한 기타 기록

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