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FDA 510(k)

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

K-Number: K172214 · 2017-08-23

ApplicantG-21 S.R.L.
Decision Date2017-08-23
Product CodeNDN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Modified Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon Catheters is a medical device manufactured by G-21 S.R.L.. It received FDA 510(k) clearance on 2017-08-23 under approval number K172214. 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 Modified Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon Catheters?

Modified Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon Catheters is a medical device that received FDA 510(k) clearance on 2017-08-23. It is manufactured by G-21 S.R.L.. The 510(k) number is K172214.

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

Modified Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon Catheters received FDA 510(k) clearance on 2017-08-23, under approval number K172214.

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

Modified Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon Catheters is manufactured by G-21 S.R.L..

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

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

Related Clinical Trials

NCT07530328 Clinical Evaluation of Copesilcup COMPLETED NCT06373666 A Study to Evaluate the Adjustment Function of a Modified Spatz3 Adjustable Balloon (Spatz4). COMPLETED NCT07408726 Monoaxial vs. Polyaxial Percutaneous Hybrid Stabilization NOT_YET_RECRUITING

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. 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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