KHEIRON® Spinal Fixation System, including patient specific K-ROD
K-Number: K253990 · 2026-01-07
ApplicantS.M.A.I.O
Decision Date2026-01-07
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
KHEIRON® Spinal Fixation System, including patient specific K-ROD is a medical device manufactured by S.M.A.I.O. It received FDA 510(k) clearance on 2026-01-07 under approval number K253990. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
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 2026-01-07. It is manufactured by S.M.A.I.O. The 510(k) number is K253990.
When was KHEIRON® Spinal Fixation System, including patient specific K-ROD approved by the FDA?
KHEIRON® Spinal Fixation System, including patient specific K-ROD received FDA 510(k) clearance on 2026-01-07, under approval number K253990.
What company makes KHEIRON® Spinal Fixation System, including patient specific K-ROD?
KHEIRON® Spinal Fixation System, including patient specific K-ROD is manufactured by S.M.A.I.O.
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.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.