FDA 510(k)

뼈 볼트 시스템

K-번호: K230867 · 2023-06-26

신청자University of Utah, Department of Orthopaedics

결정일2023-06-26

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

결정Substantially Equivalent

기기 요약

Bone Bolt System is the device name listed in this FDA 510(k) record. The listed applicant is University of Utah, Department of Orthopaedics. It received FDA 510(k) clearance on 2023-06-26 under 510(k) number K230867. 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 Bone Bolt System?

Bone Bolt System is a medical device that received FDA 510(k) clearance on 2023-06-26. The listed applicant is University of Utah, Department of Orthopaedics. The 510(k) number is K230867.

When did Bone Bolt System receive FDA 510(k) clearance?

Bone Bolt System received FDA 510(k) clearance on 2023-06-26, under 510(k) number K230867.

Who is the listed applicant for Bone Bolt System?

The FDA 510(k) record lists University of Utah, Department of Orthopaedics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Bone Bolt System?

The FDA product code for Bone Bolt System is HWC. This falls under the Cardiovascular category.

University of Utah, Department of Orthopaedics를 신청인으로 등재한 기타 기록

K252699CoAptix S 시스템

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