FDA 510(k)

PathLoc-TA Expandable Lumbar Cage System

K-번호: K223474 · 2023-01-13

결정일2023-01-13

제품 코드MAX

자문 위원회OR

결정Substantially Equivalent

기기 요약

PathLoc-TA Expandable Lumbar Cage System is the device name listed in this FDA 510(k) record. The listed applicant is L&K BIOMED Co., Ltd.. It received FDA 510(k) clearance on 2023-01-13 under 510(k) number K223474. 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 PathLoc-TA Expandable Lumbar Cage System?

PathLoc-TA Expandable Lumbar Cage System is a medical device that received FDA 510(k) clearance on 2023-01-13. The listed applicant is L&K BIOMED Co., Ltd.. The 510(k) number is K223474.

When did PathLoc-TA Expandable Lumbar Cage System receive FDA 510(k) clearance?

PathLoc-TA Expandable Lumbar Cage System received FDA 510(k) clearance on 2023-01-13, under 510(k) number K223474.

Who is the listed applicant for PathLoc-TA Expandable Lumbar Cage System?

The FDA 510(k) record lists L&K BIOMED Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PathLoc-TA Expandable Lumbar Cage System?

The FDA product code for PathLoc-TA Expandable Lumbar Cage System is MAX.

L&K BIOMED Co., Ltd.를 신청인으로 등재한 기타 기록

K262489블루엑스 경추 확장 가능 케이지 시스템 K260840블루엑스 경추 확장 가능 케이지 시스템 K261112캐슬로크-P 전방 경추 판 시스템 K261130AccelFix Spinal Fixation System K260448캐슬로크 Pectus 바 시스템 K251940PathLoc Lumbar Plate System

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