FDA 510(k)

ActivOrtho Continuous Compression Screw System

K-번호: K191817 · 2019-07-26

결정일2019-07-26

제품 코드HWC

자문 위원회의료장비 규제 텍스트 번역 [회사명]의 [제품명]은 미국 식품의약국(FDA)에 등록된 의료장비로, 510(k) 신청을 통해 승인받았습니다. PMA(Premarket Approval) 신청이 진행 중이며, 연구 등록 번호(NCT)는 [NCT 번호]입니다. 논문 등록 번호(PMID)는 [PMID 번호]입니다. 더 자세한 정보는 다음 URL을 참조하세요: [URL] 정책: medical-regulatory-v1

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기기 요약

ActivOrtho Continuous Compression Screw System is the device name listed in this FDA 510(k) record. The listed applicant is Activortho, Inc.. It received FDA 510(k) clearance on 2019-07-26 under 510(k) number K191817. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the ActivOrtho Continuous Compression Screw System?

ActivOrtho Continuous Compression Screw System is a medical device that received FDA 510(k) clearance on 2019-07-26. The listed applicant is Activortho, Inc.. The 510(k) number is K191817.

When did ActivOrtho Continuous Compression Screw System receive FDA 510(k) clearance?

ActivOrtho Continuous Compression Screw System received FDA 510(k) clearance on 2019-07-26, under 510(k) number K191817.

Who is the listed applicant for ActivOrtho Continuous Compression Screw System?

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

What is the FDA product code for ActivOrtho Continuous Compression Screw System?

The FDA product code for ActivOrtho Continuous Compression Screw System is HWC. This falls under the Cardiovascular category.

Activortho, Inc.를 신청인으로 등재한 기타 기록

K181610ActivOrtho Nitinol Compression Screw System

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