FDA 510(k)

네비게이드드 피디클 액세스 키트

K-번호: K191012 · 2019-08-07

결정일2019-08-07

제품 코드OLO

자문 위원회NE (이 문서는 원문이 제공되지 않았기 때문에 번역할 수 없습니다. 원문을 제공해 주시면 번역을 도와드리겠습니다.)

결정대체적으로 동일

기기 요약

Navigated Pedicle Access Kit is the device name listed in this FDA 510(k) record. The listed applicant is Izi Medical Products, LLC. It received FDA 510(k) clearance on 2019-08-07 under 510(k) number K191012. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Navigated Pedicle Access Kit?

Navigated Pedicle Access Kit is a medical device that received FDA 510(k) clearance on 2019-08-07. The listed applicant is Izi Medical Products, LLC. The 510(k) number is K191012.

When did Navigated Pedicle Access Kit receive FDA 510(k) clearance?

Navigated Pedicle Access Kit received FDA 510(k) clearance on 2019-08-07, under 510(k) number K191012.

Who is the listed applicant for Navigated Pedicle Access Kit?

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

What is the FDA product code for Navigated Pedicle Access Kit?

The FDA product code for Navigated Pedicle Access Kit is OLO.

Izi Medical Products, LLC를 신청인으로 등재한 기타 기록

K162265CushionCast Moldable Cushions

공식 출처

FDA 데이터베이스에서 보기 →

FDA Open API에서 수집된 데이터입니다. 가장 정확하고 공인된 정보는 항상 공식 레코드를 참조하시기 바랍니다.