FDA 510(k)

에레간스 IM 랜스드 나일 시스템 (IM 랜스드 나일 시스템)

K-번호: K252312 · 2025-10-10

신청자Dev4

결정일2025-10-10

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

결정대체적으로 동일

기기 요약

Eleganz IM Threaded Nail System (IM Threaded Nail System) is the device name listed in this FDA 510(k) record. The listed applicant is Dev4. It received FDA 510(k) clearance on 2025-10-10 under 510(k) number K252312. 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 Eleganz IM Threaded Nail System (IM Threaded Nail System)?

Eleganz IM Threaded Nail System (IM Threaded Nail System) is a medical device that received FDA 510(k) clearance on 2025-10-10. The listed applicant is Dev4. The 510(k) number is K252312.

When did Eleganz IM Threaded Nail System (IM Threaded Nail System) receive FDA 510(k) clearance?

Eleganz IM Threaded Nail System (IM Threaded Nail System) received FDA 510(k) clearance on 2025-10-10, under 510(k) number K252312.

Who is the listed applicant for Eleganz IM Threaded Nail System (IM Threaded Nail System)?

The FDA 510(k) record lists Dev4 as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Eleganz IM Threaded Nail System (IM Threaded Nail System)?

The FDA product code for Eleganz IM Threaded Nail System (IM Threaded Nail System) is HWC. This falls under the Cardiovascular category.

Dev4를 신청인으로 등재한 기타 기록

K250251에레간스 퓨전 스크루 시스템 (퓨전 스크루 시스템)

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