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FDA 510(k)

TRACKER Plus Kyphoplasty System

K-Number: K211797 · 2021-10-28

ApplicantGS Medical Co., Ltd.
Decision Date2021-10-28
Product CodeNDN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TRACKER Plus Kyphoplasty System is the device name listed in this FDA 510(k) record. The listed applicant is GS Medical Co., Ltd.. It received FDA 510(k) clearance on 2021-10-28 under 510(k) number K211797. The device is classified under product code NDN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRACKER Plus Kyphoplasty System?

TRACKER Plus Kyphoplasty System is a medical device that received FDA 510(k) clearance on 2021-10-28. The listed applicant is GS Medical Co., Ltd.. The 510(k) number is K211797.

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

TRACKER Plus Kyphoplasty System received FDA 510(k) clearance on 2021-10-28, under 510(k) number K211797.

Who is the listed applicant for TRACKER Plus Kyphoplasty System?

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

What is the FDA product code for TRACKER Plus Kyphoplasty System?

The FDA product code for TRACKER Plus Kyphoplasty System is NDN.

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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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