Osteo-site Vertebral Balloon
K-Number: K200763 · 2020-08-12
ApplicantIzi Medical
Decision Date2020-08-12
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Osteo-site Vertebral Balloon is a medical device manufactured by Izi Medical. It received FDA 510(k) clearance on 2020-08-12 under approval number K200763. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Osteo-site Vertebral Balloon?
Osteo-site Vertebral Balloon is a medical device that received FDA 510(k) clearance on 2020-08-12. It is manufactured by Izi Medical. The 510(k) number is K200763.
When was Osteo-site Vertebral Balloon approved by the FDA?
Osteo-site Vertebral Balloon received FDA 510(k) clearance on 2020-08-12, under approval number K200763.
What company makes Osteo-site Vertebral Balloon?
Osteo-site Vertebral Balloon is manufactured by Izi Medical.
What is the FDA product code for Osteo-site Vertebral Balloon?
The FDA product code for Osteo-site Vertebral Balloon is HRX.
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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.