FDA 510(k)

cranial LOOP, cranial LOOP L, cranial LOOP XL 뇌골 고정 시스템

K-번호: K240137 · 2024-02-16

결정일2024-02-16

제품 코드GXR

자문 위원회NE (이 문서는 원문이 제공되지 않았기 때문에 번역할 수 없습니다. 원문을 제공해 주시면 번역을 도와드리겠습니다.)

결정대체적으로 동일

기기 요약

Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bone Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Neos Surgery S.L. It received FDA 510(k) clearance on 2024-02-16 under 510(k) number K240137. The device is classified under product code GXR. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bone Fixation System?

Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bone Fixation System is a medical device that received FDA 510(k) clearance on 2024-02-16. The listed applicant is Neos Surgery S.L. The 510(k) number is K240137.

When did Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bone Fixation System receive FDA 510(k) clearance?

Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bone Fixation System received FDA 510(k) clearance on 2024-02-16, under 510(k) number K240137.

Who is the listed applicant for Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bone Fixation System?

The FDA 510(k) record lists Neos Surgery S.L as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bone Fixation System?

The FDA product code for Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bone Fixation System is GXR.

Neos Surgery S.L를 신청인으로 등재한 기타 기록

K221795스터인 픽스 스테르널 스탬일라이제이션 시스템 K211613스터른 파이크 스테르널 스탬일라이제이션 시스템 K160739뇌 씻기盖

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