FDA 510(k)

인슐 헬덴 히드램 팔 관절 수술 도구, 인슐 헬덴 캔빌레이드 티베리얼 관절 수술 도구, 인슐 헬덴 대퇴 관절 수술 도구 및 인슐 헬덴 후방 대퇴 관절 수술 도구

K-번호: K172189 · 2018-01-16

결정일2018-01-16

제품 코드HSB

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

Ins Hilden Humeral Arzzt, Ins Hilden Cannulated Tibial Arzzt, Ins Hilden Femoral Arzzt & Ins Hilden Retrograde Femoral Arzzt is the device name listed in this FDA 510(k) record. The listed applicant is Truemed Group, LLC. It received FDA 510(k) clearance on 2018-01-16 under 510(k) number K172189. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Ins Hilden Humeral Arzzt, Ins Hilden Cannulated Tibial Arzzt, Ins Hilden Femoral Arzzt & Ins Hilden Retrograde Femoral Arzzt?

Ins Hilden Humeral Arzzt, Ins Hilden Cannulated Tibial Arzzt, Ins Hilden Femoral Arzzt & Ins Hilden Retrograde Femoral Arzzt is a medical device that received FDA 510(k) clearance on 2018-01-16. The listed applicant is Truemed Group, LLC. The 510(k) number is K172189.

When did Ins Hilden Humeral Arzzt, Ins Hilden Cannulated Tibial Arzzt, Ins Hilden Femoral Arzzt & Ins Hilden Retrograde Femoral Arzzt receive FDA 510(k) clearance?

Ins Hilden Humeral Arzzt, Ins Hilden Cannulated Tibial Arzzt, Ins Hilden Femoral Arzzt & Ins Hilden Retrograde Femoral Arzzt received FDA 510(k) clearance on 2018-01-16, under 510(k) number K172189.

Who is the listed applicant for Ins Hilden Humeral Arzzt, Ins Hilden Cannulated Tibial Arzzt, Ins Hilden Femoral Arzzt & Ins Hilden Retrograde Femoral Arzzt?

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

What is the FDA product code for Ins Hilden Humeral Arzzt, Ins Hilden Cannulated Tibial Arzzt, Ins Hilden Femoral Arzzt & Ins Hilden Retrograde Femoral Arzzt?

The FDA product code for Ins Hilden Humeral Arzzt, Ins Hilden Cannulated Tibial Arzzt, Ins Hilden Femoral Arzzt & Ins Hilden Retrograde Femoral Arzzt is HSB.

Truemed Group, LLC를 신청인으로 등재한 기타 기록

K200575TRUEMED 손, 발, 무릎 판 시스템 K182650Arzzt Distal Radius and Ulna System K162507Arzzt 3.5 / 4.5 소형 및 대형 파편 시스템

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