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Osteo-site Vertebral Balloon — Izi Medical (510(k) K200763)

Osteo-site Vertebral Balloon — Izi Medical (510(k) K200763) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: Osteo-site Vertebral Balloon; Applicant: Izi Medical; Clearance track: 510(k).

Device nameOsteo-site Vertebral Balloon
ApplicantIzi Medical
Clearance track510(k)
Submission numberK200763
DecisionSubstantially Equivalent
Decision date2020-08-12
Date received2020-03-24
Product codeHRX
Device class2
Medical specialtyOrthopedic
Applicant locationMD, US
SourceopenFDA device

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