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FDA 510(k)

TRACKER Kyphoplasty System

K-Number: K192335 · 2019-12-04

ApplicantGS Medical Co., Ltd.
Decision Date2019-12-04
Product CodeNDN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TRACKER 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 2019-12-04 under 510(k) number K192335. 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 Kyphoplasty System?

TRACKER Kyphoplasty System is a medical device that received FDA 510(k) clearance on 2019-12-04. The listed applicant is GS Medical Co., Ltd.. The 510(k) number is K192335.

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

TRACKER Kyphoplasty System received FDA 510(k) clearance on 2019-12-04, under 510(k) number K192335.

Who is the listed applicant for TRACKER 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 Kyphoplasty System?

The FDA product code for TRACKER 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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