FDA 510(k)

HEDRON Cervical Spacers (HEDRON C-MIS Spacer)

K-Number: K253876 · 2025-12-22

Decision Date2025-12-22

Product CodeOVE

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

HEDRON Cervical Spacers (HEDRON C-MIS Spacer) is a medical device manufactured by Globus Medical, Inc.. It received FDA 510(k) clearance on 2025-12-22 under approval number K253876. The device is classified under product code OVE. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEDRON Cervical Spacers (HEDRON C-MIS Spacer)?

HEDRON Cervical Spacers (HEDRON C-MIS Spacer) is a medical device that received FDA 510(k) clearance on 2025-12-22. It is manufactured by Globus Medical, Inc.. The 510(k) number is K253876.

When was HEDRON Cervical Spacers (HEDRON C-MIS Spacer) approved by the FDA?

HEDRON Cervical Spacers (HEDRON C-MIS Spacer) received FDA 510(k) clearance on 2025-12-22, under approval number K253876.

What company makes HEDRON Cervical Spacers (HEDRON C-MIS Spacer)?

HEDRON Cervical Spacers (HEDRON C-MIS Spacer) is manufactured by Globus Medical, Inc..

What is the FDA product code for HEDRON Cervical Spacers (HEDRON C-MIS Spacer)?

The FDA product code for HEDRON Cervical Spacers (HEDRON C-MIS Spacer) is OVE.

Related Clinical Trials

NCT06938607 Post-operative Outcomes of Anterior Cervical Discectomy and Fusion Surgery With and Without Drain Placement NOT_YET_RECRUITING NCT07300631 SpaceOAR Post-Market Registry Study RECRUITING

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: OVE)

K162531STERISPINE CCSafe Orthopaedics K162944Irix-C Cervical Integrated Fusion SystemX-Spine Systems, Inc. K160313Xenco Medical Cervical Interbody SystemXenco Medical, LLC K161442NuVasive® CoRoent® Small Interlock SystemNu Vasive, Incorporated K161081SeaSpine Shoreline ACS - Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation K160066Pro-Link® Stand-Alone Cervical Spacer SystemLife Spine, 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.