FDA 510(k)

Arzzt 3.5 / 4.5 소형 및 대형 파편 시스템

K-번호: K162507 · 2017-08-03

결정일2017-08-03

제품 코드HRS

자문 위원회OR

결정Substantially Equivalent

기기 요약

Arzzt 3.5 / 4.5 Small & Large Fragments System 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 2017-08-03 under 510(k) number K162507. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Arzzt 3.5 / 4.5 Small & Large Fragments System?

Arzzt 3.5 / 4.5 Small & Large Fragments System is a medical device that received FDA 510(k) clearance on 2017-08-03. The listed applicant is Truemed Group, LLC. The 510(k) number is K162507.

When did Arzzt 3.5 / 4.5 Small & Large Fragments System receive FDA 510(k) clearance?

Arzzt 3.5 / 4.5 Small & Large Fragments System received FDA 510(k) clearance on 2017-08-03, under 510(k) number K162507.

Who is the listed applicant for Arzzt 3.5 / 4.5 Small & Large Fragments System?

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 Arzzt 3.5 / 4.5 Small & Large Fragments System?

The FDA product code for Arzzt 3.5 / 4.5 Small & Large Fragments System is HRS.

Truemed Group, LLC를 신청인으로 등재한 기타 기록

K200575TRUEMED HAND, FOOT AND ANKLE PLATES SYSTEM K182650Arzzt Distal Radius and Ulna System K172189인슐 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

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