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FDA 510(k)

Kyphoplasty Balloon System

K-Number: K221142 · 2023-04-21

ApplicantOK Medinet Korea Co., Ltd.
Decision Date2023-04-21
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Kyphoplasty Balloon System is a medical device manufactured by OK Medinet Korea Co., Ltd.. It received FDA 510(k) clearance on 2023-04-21 under approval number K221142. 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 Kyphoplasty Balloon System?

Kyphoplasty Balloon System is a medical device that received FDA 510(k) clearance on 2023-04-21. It is manufactured by OK Medinet Korea Co., Ltd.. The 510(k) number is K221142.

When was Kyphoplasty Balloon System approved by the FDA?

Kyphoplasty Balloon System received FDA 510(k) clearance on 2023-04-21, under approval number K221142.

What company makes Kyphoplasty Balloon System?

Kyphoplasty Balloon System is manufactured by OK Medinet Korea Co., Ltd..

What is the FDA product code for Kyphoplasty Balloon System?

The FDA product code for Kyphoplasty Balloon System is HRX.

Related Clinical Trials

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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.

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