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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Izi Medical. It received FDA 510(k) clearance on 2020-08-12 under 510(k) 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. The listed applicant is Izi Medical. The 510(k) number is K200763.

When did Osteo-site Vertebral Balloon receive FDA 510(k) clearance?

Osteo-site Vertebral Balloon received FDA 510(k) clearance on 2020-08-12, under 510(k) number K200763.

Who is the listed applicant for Osteo-site Vertebral Balloon?

The FDA 510(k) record lists Izi Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Osteo-site Vertebral Balloon?

The FDA product code for Osteo-site Vertebral Balloon is HRX.

Related Devices (Code: HRX)

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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