Xpine Spinal Fixation System
K-Number: K243004 · 2024-11-08
ApplicantJeil Medical Corporation
Decision Date2024-11-08
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Xpine Spinal Fixation System is a medical device manufactured by Jeil Medical Corporation. It received FDA 510(k) clearance on 2024-11-08 under approval number K243004. 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 Xpine Spinal Fixation System?
Xpine Spinal Fixation System is a medical device that received FDA 510(k) clearance on 2024-11-08. It is manufactured by Jeil Medical Corporation. The 510(k) number is K243004.
When was Xpine Spinal Fixation System approved by the FDA?
Xpine Spinal Fixation System received FDA 510(k) clearance on 2024-11-08, under approval number K243004.
What company makes Xpine Spinal Fixation System?
Xpine Spinal Fixation System is manufactured by Jeil Medical Corporation.
What is the FDA product code for Xpine Spinal Fixation System?
The FDA product code for Xpine Spinal Fixation System 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.