FDA 510(k)

FasTouch Fixation System

K-번호: K162252 · 2016-11-14

결정일2016-11-14

제품 코드GDW

자문 위원회SU

결정Substantially Equivalent

기기 요약

FasTouch Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Via Surgical , Ltd.. It received FDA 510(k) clearance on 2016-11-14 under 510(k) number K162252. The device is classified under product code GDW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the FasTouch Fixation System?

FasTouch Fixation System is a medical device that received FDA 510(k) clearance on 2016-11-14. The listed applicant is Via Surgical , Ltd.. The 510(k) number is K162252.

When did FasTouch Fixation System receive FDA 510(k) clearance?

FasTouch Fixation System received FDA 510(k) clearance on 2016-11-14, under 510(k) number K162252.

Who is the listed applicant for FasTouch Fixation System?

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

What is the FDA product code for FasTouch Fixation System?

The FDA product code for FasTouch Fixation System is GDW.

Via Surgical , Ltd.를 신청인으로 등재한 기타 기록

K203117TissueTak device K181668FasTouch Absorbable Fixation System

관련 기기 (코드: GDW)

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