FDA 510(k)

CROSSWAY Spinal Access System

K-Number: K190598 · 2019-04-05

Decision Date2019-04-05

Product CodeHRX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

CROSSWAY Spinal Access System is a medical device manufactured by Globus Medical, Inc.. It received FDA 510(k) clearance on 2019-04-05 under approval number K190598. 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 CROSSWAY Spinal Access System?

CROSSWAY Spinal Access System is a medical device that received FDA 510(k) clearance on 2019-04-05. It is manufactured by Globus Medical, Inc.. The 510(k) number is K190598.

When was CROSSWAY Spinal Access System approved by the FDA?

CROSSWAY Spinal Access System received FDA 510(k) clearance on 2019-04-05, under approval number K190598.

What company makes CROSSWAY Spinal Access System?

CROSSWAY Spinal Access System is manufactured by Globus Medical, Inc..

What is the FDA product code for CROSSWAY Spinal Access System?

The FDA product code for CROSSWAY Spinal Access System is HRX.

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Related PubMed Literature

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Other Devices by Globus Medical, Inc.

K161379ELSA Spacers K161591QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments K160597INDEPENDENCE MIS Spacers K161223TransContinental® M Spacers and InterContinental® Plate-Spacers K143578SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS Spacers, INDEPENDENCE TPS Spacer, FORTIFY -R TPS Corpectomy Spacer, FORTIFY I-R TPS Corpectomy Spacer, XPand -R TPS Corpectomy Spacer, NIKO TPS Corpectomy Spacer K151665SUSTAIN Additional Implants

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Related Devices (Code: HRX)

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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.