KHEIRON® Spinal Fixation System, including patient specific K-ROD
K-Number: K232650 · 2023-09-29
ApplicantS.M.A.I.O
Decision Date2023-09-29
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 2023-09-29 under approval number K232650. 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 2023-09-29. It is manufactured by S.M.A.I.O. The 510(k) number is K232650.
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 2023-09-29, under approval number K232650.
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.