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FDA 510(k)

Stryker iVAS Elite Inflatable Vertebral Augmentation System (Stryker iVAS Elite Balloon Catheter)

K-Number: K181752 · 2018-12-21

ApplicantStryker Corporation
Decision Date2018-12-21
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Stryker iVAS Elite Inflatable Vertebral Augmentation System (Stryker iVAS Elite Balloon Catheter) is a medical device manufactured by Stryker Corporation. It received FDA 510(k) clearance on 2018-12-21 under approval number K181752. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Stryker iVAS Elite Inflatable Vertebral Augmentation System (Stryker iVAS Elite Balloon Catheter)?

Stryker iVAS Elite Inflatable Vertebral Augmentation System (Stryker iVAS Elite Balloon Catheter) is a medical device that received FDA 510(k) clearance on 2018-12-21. It is manufactured by Stryker Corporation. The 510(k) number is K181752.

When was Stryker iVAS Elite Inflatable Vertebral Augmentation System (Stryker iVAS Elite Balloon Catheter) approved by the FDA?

Stryker iVAS Elite Inflatable Vertebral Augmentation System (Stryker iVAS Elite Balloon Catheter) received FDA 510(k) clearance on 2018-12-21, under approval number K181752.

What company makes Stryker iVAS Elite Inflatable Vertebral Augmentation System (Stryker iVAS Elite Balloon Catheter)?

Stryker iVAS Elite Inflatable Vertebral Augmentation System (Stryker iVAS Elite Balloon Catheter) is manufactured by Stryker Corporation.

What is the FDA product code for Stryker iVAS Elite Inflatable Vertebral Augmentation System (Stryker iVAS Elite Balloon Catheter)?

The FDA product code for Stryker iVAS Elite Inflatable Vertebral Augmentation System (Stryker iVAS Elite Balloon Catheter) is HRX.

Related Clinical Trials

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Related PubMed Literature

PMID: 40407411 A data augmentation approach for an automatic speech recognition system using laser Doppler vibrometer technology. JASA express letters (2025)

Other Devices by Stryker Corporation

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Related Devices (Code: HRX)

K162062AVAmax Vertebral Balloon, AVAflex Vertebral BalloonStryker Corporation K161878PORTAGE SystemBaylis Medical Company, Inc. K162475mi-eye 2, mi-eye 2 monitorTrice Medical K152511Neo - Arthroscope (Rigid) 2.0mm/3.5mm, Outer sheath/ cannula, Outer sheath/ cannula w/ Handle, Trocar for outersheath/ cannulaProsurg, Inc. K160249ULTRA TelescopesOlympus Winter & Ibe GmbH K151932Stryker CrossFlow Day-Use Inflow Cassette Tubing and Patient-Use TubingStryker Corporation

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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