FDA 510(k)

restor3d TIDAL Lumbar Interbody Fusion System

K-번호: K234087 · 2024-01-22

결정일2024-01-22

제품 코드MAX

자문 위원회OR

결정Substantially Equivalent

기기 요약

restor3d TIDAL Lumbar Interbody Fusion System is the device name listed in this FDA 510(k) record. The listed applicant is Restor3D. It received FDA 510(k) clearance on 2024-01-22 under 510(k) number K234087. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the restor3d TIDAL Lumbar Interbody Fusion System?

restor3d TIDAL Lumbar Interbody Fusion System is a medical device that received FDA 510(k) clearance on 2024-01-22. The listed applicant is Restor3D. The 510(k) number is K234087.

When did restor3d TIDAL Lumbar Interbody Fusion System receive FDA 510(k) clearance?

restor3d TIDAL Lumbar Interbody Fusion System received FDA 510(k) clearance on 2024-01-22, under 510(k) number K234087.

Who is the listed applicant for restor3d TIDAL Lumbar Interbody Fusion System?

The FDA 510(k) record lists Restor3D as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for restor3d TIDAL Lumbar Interbody Fusion System?

The FDA product code for restor3d TIDAL Lumbar Interbody Fusion System is MAX.

Restor3D를 신청인으로 등재한 기타 기록

K260556Veritas Shoulder System K253992Veritas Reverse Total Shoulder System K252454Kinos Total Ankle System K243643restor3d Reverse Total Shoulder Arthroplasty System K242868Kinos Total Ankle System K241482Kinos Total Ankle System

13개 장치 모두 보기 →

공식 출처

FDA 데이터베이스에서 보기 →

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