VirtuOst Vertebral Fracture Assessment
K-Number: K171435 · 2018-08-03
ApplicantO.N. Diagnostics, LLC
Decision Date2018-08-03
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
VirtuOst Vertebral Fracture Assessment is a medical device manufactured by O.N. Diagnostics, LLC. It received FDA 510(k) clearance on 2018-08-03 under approval number K171435. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the VirtuOst Vertebral Fracture Assessment?
VirtuOst Vertebral Fracture Assessment is a medical device that received FDA 510(k) clearance on 2018-08-03. It is manufactured by O.N. Diagnostics, LLC. The 510(k) number is K171435.
When was VirtuOst Vertebral Fracture Assessment approved by the FDA?
VirtuOst Vertebral Fracture Assessment received FDA 510(k) clearance on 2018-08-03, under approval number K171435.
What company makes VirtuOst Vertebral Fracture Assessment?
VirtuOst Vertebral Fracture Assessment is manufactured by O.N. Diagnostics, LLC.
What is the FDA product code for VirtuOst Vertebral Fracture Assessment?
The FDA product code for VirtuOst Vertebral Fracture Assessment is LLZ.
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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.