FDA 510(k)

OptiFix AT 흡수 가능 고정 시스템 및 조절 기술 – 30 개 고정자, OptiFix AT 흡수 가능 고정 시스템 및 조절 기술 – 15 개 고정자

K-번호: K191287 · 2019-07-16

결정일2019-07-16

제품 코드GDW

자문 위원회SU [원문이 제공되지 않았기 때문에 번역할 수 없습니다. 원문을 제공해 주시면 번역을 도와드리겠습니다.]

결정대체적으로 동일

기기 요약

OptiFix AT Absorbable Fixation System with Articulating Technology – 30 Fasteners, OptiFix AT Absorbable Fixation System with Articulating Technology – 15 Fasteners is the device name listed in this FDA 510(k) record. The listed applicant is Davol Inc., Subsidiary of C.R. Bard. It received FDA 510(k) clearance on 2019-07-16 under 510(k) number K191287. 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 OptiFix AT Absorbable Fixation System with Articulating Technology – 30 Fasteners, OptiFix AT Absorbable Fixation System with Articulating Technology – 15 Fasteners?

OptiFix AT Absorbable Fixation System with Articulating Technology – 30 Fasteners, OptiFix AT Absorbable Fixation System with Articulating Technology – 15 Fasteners is a medical device that received FDA 510(k) clearance on 2019-07-16. The listed applicant is Davol Inc., Subsidiary of C.R. Bard. The 510(k) number is K191287.

When did OptiFix AT Absorbable Fixation System with Articulating Technology – 30 Fasteners, OptiFix AT Absorbable Fixation System with Articulating Technology – 15 Fasteners receive FDA 510(k) clearance?

OptiFix AT Absorbable Fixation System with Articulating Technology – 30 Fasteners, OptiFix AT Absorbable Fixation System with Articulating Technology – 15 Fasteners received FDA 510(k) clearance on 2019-07-16, under 510(k) number K191287.

Who is the listed applicant for OptiFix AT Absorbable Fixation System with Articulating Technology – 30 Fasteners, OptiFix AT Absorbable Fixation System with Articulating Technology – 15 Fasteners?

The FDA 510(k) record lists Davol Inc., Subsidiary of C.R. Bard as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OptiFix AT Absorbable Fixation System with Articulating Technology – 30 Fasteners, OptiFix AT Absorbable Fixation System with Articulating Technology – 15 Fasteners?

The FDA product code for OptiFix AT Absorbable Fixation System with Articulating Technology – 30 Fasteners, OptiFix AT Absorbable Fixation System with Articulating Technology – 15 Fasteners is GDW.

공식 출처

FDA 데이터베이스에서 보기 →

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

OptiFix AT 흡수 가능 고정 시스템 및 조절 기술 – 30 개 고정자, OptiFix AT 흡수 가능 고정 시스템 및 조절 기술 – 15 개 고정자

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: GDW)

공식 출처