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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 the device name listed in this FDA 510(k) record. The listed applicant is OK Medinet Korea Co., Ltd.. It received FDA 510(k) clearance on 2023-04-21 under 510(k) 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. The listed applicant is OK Medinet Korea Co., Ltd.. The 510(k) number is K221142.

When did Kyphoplasty Balloon System receive FDA 510(k) clearance?

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

Who is the listed applicant for Kyphoplasty Balloon System?

The FDA 510(k) record lists OK Medinet Korea Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Kyphoplasty Balloon System?

The FDA product code for Kyphoplasty Balloon System 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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