FDA 510(k)

CenterMed 환자 맞춤형 수술 계획(ASP) 시스템

K-번호: K211614 · 2022-08-04

결정일2022-08-04

제품 코드PBF

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

CenterMed Patient Matched Assisted Surgical Planning (ASP) System is the device name listed in this FDA 510(k) record. The listed applicant is Centermed, Inc.. It received FDA 510(k) clearance on 2022-08-04 under 510(k) number K211614. The device is classified under product code PBF. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the CenterMed Patient Matched Assisted Surgical Planning (ASP) System?

CenterMed Patient Matched Assisted Surgical Planning (ASP) System is a medical device that received FDA 510(k) clearance on 2022-08-04. The listed applicant is Centermed, Inc.. The 510(k) number is K211614.

When did CenterMed Patient Matched Assisted Surgical Planning (ASP) System receive FDA 510(k) clearance?

CenterMed Patient Matched Assisted Surgical Planning (ASP) System received FDA 510(k) clearance on 2022-08-04, under 510(k) number K211614.

Who is the listed applicant for CenterMed Patient Matched Assisted Surgical Planning (ASP) System?

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

What is the FDA product code for CenterMed Patient Matched Assisted Surgical Planning (ASP) System?

The FDA product code for CenterMed Patient Matched Assisted Surgical Planning (ASP) System is PBF.

Centermed, Inc.를 신청인으로 등재한 기타 기록

K201353CenterMed 환자 맞춤형 수술 계획(ASP) 시스템

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