FDA 510(k)

HC 바이올로지크스 오스토파인 스파인 파이크션 시스템

K-번호: K250092 · 2025-03-27

결정일2025-03-27

제품 코드NKB

자문 위원회OR

결정Substantially Equivalent

기기 요약

HC Biologics Osteopoint Spinal Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is HC Biologics, LLC. It received FDA 510(k) clearance on 2025-03-27 under 510(k) number K250092. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the HC Biologics Osteopoint Spinal Fixation System?

HC Biologics Osteopoint Spinal Fixation System is a medical device that received FDA 510(k) clearance on 2025-03-27. The listed applicant is HC Biologics, LLC. The 510(k) number is K250092.

When did HC Biologics Osteopoint Spinal Fixation System receive FDA 510(k) clearance?

HC Biologics Osteopoint Spinal Fixation System received FDA 510(k) clearance on 2025-03-27, under 510(k) number K250092.

Who is the listed applicant for HC Biologics Osteopoint Spinal Fixation System?

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

What is the FDA product code for HC Biologics Osteopoint Spinal Fixation System?

The FDA product code for HC Biologics Osteopoint Spinal Fixation System is NKB.

HC Biologics, LLC를 신청인으로 등재한 기타 기록

K260340HC BIOLOGICS OSTEOPOINT PEEK 케이지, HC BIOLOGICS OSTEOPOINT 목脊椎 PEEK 케이지, HC BIOLOGICS OSTEOPOINT 척추 PEEK 케이지

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