FDA 510(k)

VERASENSE for Stryker 트라이아스온

K-번호: K200665 · 2020-04-12

결정일2020-04-12

제품 코드ONN

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

결정대체적으로 동일

기기 요약

VERASENSE for Stryker Triathlon is the device name listed in this FDA 510(k) record. The listed applicant is Orthosensor, Inc.. It received FDA 510(k) clearance on 2020-04-12 under 510(k) number K200665. The device is classified under product code ONN. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the VERASENSE for Stryker Triathlon?

VERASENSE for Stryker Triathlon is a medical device that received FDA 510(k) clearance on 2020-04-12. The listed applicant is Orthosensor, Inc.. The 510(k) number is K200665.

When did VERASENSE for Stryker Triathlon receive FDA 510(k) clearance?

VERASENSE for Stryker Triathlon received FDA 510(k) clearance on 2020-04-12, under 510(k) number K200665.

Who is the listed applicant for VERASENSE for Stryker Triathlon?

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

What is the FDA product code for VERASENSE for Stryker Triathlon?

The FDA product code for VERASENSE for Stryker Triathlon is ONN.

Orthosensor, Inc.를 신청인으로 등재한 기타 기록

K200587VERASENSE for Exactech Equinoxe Size 38 mm, VERASENSE for Exactech Equinoxe Size 42 mm, LinkStation MINI, LinkStation MINI 평가 키트, VERASENSE 소프트웨어 애플리케이션 for 어깨 K193580VERASENSE for Zimmer Biomet Persona CR C-D/3-9 왼쪽, VERASENSE for Zimmer Biomet Persona CR C-D/3-9 오른쪽, VERASENSE for Zimmer Biomet Persona CR E-F/3-11 왼쪽, VERASENSE for Zimmer Biomet Persona CR E-F/3-11 오른쪽, VERASENSE for Zimmer Biomet Persona CR G-H/7-12 왼쪽 K180459VERASENSE for ZIMMER BIOMET PERSONA K150372VERASENSE 키니 시스템

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