FDA 510(k)

KHEIRON® Spinal Fixation System, including patient specific K-ROD

K-번호: K253721 · 2025-12-17

신청자S.M.A.I.O

결정일2025-12-17

제품 코드NKB

자문 위원회OR

결정Substantially Equivalent

기기 요약

KHEIRON® Spinal Fixation System, including patient specific K-ROD is the device name listed in this FDA 510(k) record. The listed applicant is S.M.A.I.O. It received FDA 510(k) clearance on 2025-12-17 under 510(k) number K253721. 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 KHEIRON® Spinal Fixation System, including patient specific K-ROD?

KHEIRON® Spinal Fixation System, including patient specific K-ROD is a medical device that received FDA 510(k) clearance on 2025-12-17. The listed applicant is S.M.A.I.O. The 510(k) number is K253721.

When did KHEIRON® Spinal Fixation System, including patient specific K-ROD receive FDA 510(k) clearance?

KHEIRON® Spinal Fixation System, including patient specific K-ROD received FDA 510(k) clearance on 2025-12-17, under 510(k) number K253721.

Who is the listed applicant for KHEIRON® Spinal Fixation System, including patient specific K-ROD?

The FDA 510(k) record lists S.M.A.I.O as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KHEIRON® Spinal Fixation System, including patient specific K-ROD?

The FDA product code for KHEIRON® Spinal Fixation System, including patient specific K-ROD is NKB.

S.M.A.I.O를 신청인으로 등재한 기타 기록

K262828KHEIRON® Spinal Fixation System, including patient specific K-ROD K261500KBA3D (v2.4.0)K253802KHEIRON® Spinal Fixation System, including patient specific K-ROD K260786KHEIRON® Spinal Fixation System, including patient specific K-ROD K253990KHEIRON® Spinal Fixation System, including patient specific K-ROD K251804KHEIRON® Spinal Fixation System, including patient specific K-ROD

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