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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is O.N. Diagnostics, LLC. It received FDA 510(k) clearance on 2018-08-03 under 510(k) 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. The listed applicant is O.N. Diagnostics, LLC. The 510(k) number is K171435.

When did VirtuOst Vertebral Fracture Assessment receive FDA 510(k) clearance?

VirtuOst Vertebral Fracture Assessment received FDA 510(k) clearance on 2018-08-03, under 510(k) number K171435.

Who is the listed applicant for VirtuOst Vertebral Fracture Assessment?

The FDA 510(k) record lists O.N. Diagnostics, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VirtuOst Vertebral Fracture Assessment?

The FDA product code for VirtuOst Vertebral Fracture Assessment is LLZ.

Other records listing O.N. Diagnostics, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K220402VirtuOst

Related Devices (Code: LLZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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