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FDA 510(k)

Winch Kyphoplasty(15 and 20 mm) 11 Gauge Balloon Catheters

K-Number: K152557 · 2016-02-23

ApplicantG21, S.R.L.
Decision Date2016-02-23
Product CodeNDN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Winch Kyphoplasty(15 and 20 mm) 11 Gauge Balloon Catheters is a medical device manufactured by G21, S.R.L.. It received FDA 510(k) clearance on 2016-02-23 under approval number K152557. 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 Winch Kyphoplasty(15 and 20 mm) 11 Gauge Balloon Catheters?

Winch Kyphoplasty(15 and 20 mm) 11 Gauge Balloon Catheters is a medical device that received FDA 510(k) clearance on 2016-02-23. It is manufactured by G21, S.R.L.. The 510(k) number is K152557.

When was Winch Kyphoplasty(15 and 20 mm) 11 Gauge Balloon Catheters approved by the FDA?

Winch Kyphoplasty(15 and 20 mm) 11 Gauge Balloon Catheters received FDA 510(k) clearance on 2016-02-23, under approval number K152557.

What company makes Winch Kyphoplasty(15 and 20 mm) 11 Gauge Balloon Catheters?

Winch Kyphoplasty(15 and 20 mm) 11 Gauge Balloon Catheters is manufactured by G21, S.R.L..

What is the FDA product code for Winch Kyphoplasty(15 and 20 mm) 11 Gauge Balloon Catheters?

The FDA product code for Winch Kyphoplasty(15 and 20 mm) 11 Gauge Balloon Catheters is NDN.

Related Clinical Trials

NCT07408726 Monoaxial vs. Polyaxial Percutaneous Hybrid Stabilization NOT_YET_RECRUITING

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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. K172214Modified Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon CathetersG-21 S.R.L. K161114HIGH V+Teknimed Sas K163032Kyphon Xpede Bone CementMedtronic, Inc.

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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