FDA 510(k)

SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS)

K-번호: K190069 · 2019-05-14

결정일2019-05-14

제품 코드KTT

자문 위원회OR

결정Substantially Equivalent

기기 요약

SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS) is the device name listed in this FDA 510(k) record. The listed applicant is Arrowhead De, LLC. It received FDA 510(k) clearance on 2019-05-14 under 510(k) number K190069. The device is classified under product code KTT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS)?

SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS) is a medical device that received FDA 510(k) clearance on 2019-05-14. The listed applicant is Arrowhead De, LLC. The 510(k) number is K190069.

When did SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS) receive FDA 510(k) clearance?

SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS) received FDA 510(k) clearance on 2019-05-14, under 510(k) number K190069.

Who is the listed applicant for SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS)?

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

What is the FDA product code for SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS)?

The FDA product code for SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS) is KTT.

Arrowhead De, LLC를 신청인으로 등재한 기타 기록

K200123SixFix® 헥사포드 fixing 액세서리 K162032아로우헤드 미니-레일 fixing 장비

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