FDA 510(k)

추가 정형외과 환자 특화 3D 프린팅 뼈 구간

K-번호: K180239 · 2018-05-16

결정일2018-05-16

제품 코드HRS

자문 위원회OR

결정Substantially Equivalent

기기 요약

Additive Orthopaedics Patient Specific 3D Printed Bone Segments is the device name listed in this FDA 510(k) record. The listed applicant is Additive Orthopaedics, LLC. It received FDA 510(k) clearance on 2018-05-16 under 510(k) number K180239. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Additive Orthopaedics Patient Specific 3D Printed Bone Segments?

Additive Orthopaedics Patient Specific 3D Printed Bone Segments is a medical device that received FDA 510(k) clearance on 2018-05-16. The listed applicant is Additive Orthopaedics, LLC. The 510(k) number is K180239.

When did Additive Orthopaedics Patient Specific 3D Printed Bone Segments receive FDA 510(k) clearance?

Additive Orthopaedics Patient Specific 3D Printed Bone Segments received FDA 510(k) clearance on 2018-05-16, under 510(k) number K180239.

Who is the listed applicant for Additive Orthopaedics Patient Specific 3D Printed Bone Segments?

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

What is the FDA product code for Additive Orthopaedics Patient Specific 3D Printed Bone Segments?

The FDA product code for Additive Orthopaedics Patient Specific 3D Printed Bone Segments is HRS.

Additive Orthopaedics, LLC를 신청인으로 등재한 기타 기록

K211076Patient Specific Marking Guides K163593추가 정형외과 발가락 골절 시스템 K170214추가 정형외과 락링 레이셋 플레이트 K153207추가 정형외과 뼈 돌기 시스템 K160264추가 정형외과 발가락 골절 교정 시스템

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