FDA 510(k)

SPIRA® Posterior Lumbar Spacers

K-번호: K230942 · 2023-07-11

결정일2023-07-11

제품 코드MAX

자문 위원회OR

결정Substantially Equivalent

기기 요약

SPIRA® Posterior Lumbar Spacers is the device name listed in this FDA 510(k) record. The listed applicant is Camber Spine Technologies. It received FDA 510(k) clearance on 2023-07-11 under 510(k) number K230942. 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 SPIRA® Posterior Lumbar Spacers?

SPIRA® Posterior Lumbar Spacers is a medical device that received FDA 510(k) clearance on 2023-07-11. The listed applicant is Camber Spine Technologies. The 510(k) number is K230942.

When did SPIRA® Posterior Lumbar Spacers receive FDA 510(k) clearance?

SPIRA® Posterior Lumbar Spacers received FDA 510(k) clearance on 2023-07-11, under 510(k) number K230942.

Who is the listed applicant for SPIRA® Posterior Lumbar Spacers?

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

What is the FDA product code for SPIRA® Posterior Lumbar Spacers?

The FDA product code for SPIRA® Posterior Lumbar Spacers is MAX.

Camber Spine Technologies를 신청인으로 등재한 기타 기록

K234077SPIRA® Anterior Lumbar Spacers K233972Camber Sacroiliac (SI) Fixation System K221324ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF)K223837SPIRA®-C Integrated Fixation System K220038Camber Spine Navigation System K193153SPIRA-C Integrated Fixation System

16개 장치 모두 보기 →

공식 출처

FDA 데이터베이스에서 보기 →

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