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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 a medical device manufactured by GS Medical Co., Ltd.. It received FDA 510(k) clearance on 2019-12-04 under approval 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. It is manufactured by GS Medical Co., Ltd.. The 510(k) number is K192335.

When was TRACKER Kyphoplasty System approved by the FDA?

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

What company makes TRACKER Kyphoplasty System?

TRACKER Kyphoplasty System is manufactured by GS Medical Co., Ltd..

What is the FDA product code for TRACKER Kyphoplasty System?

The FDA product code for TRACKER Kyphoplasty System is NDN.

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Other Devices by GS Medical Co., Ltd.

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Related Devices (Code: NDN)

K16245313G InterV Kyphoplasty Catheter (Micro) and 11G InterV Kyphoplasty Catheter (Mini-Flex)Pan Medical , Ltd. K160983Kyphon HV-R Bone CementMedtronic, Inc. K153296MEDINAUT Kyphoplasty SystemImedicom Co., Ltd. K152557Winch Kyphoplasty(15 and 20 mm) 11 Gauge Balloon CathetersG21, S.R.L. K172214Modified Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon CathetersG-21 S.R.L. K161114HIGH V+Teknimed Sas

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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