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FDA 510(k)

HEDRON Cervical Spacers

K-Number: K191243 · 2019-09-17

ApplicantGlobus Medical, Inc.
Decision Date2019-09-17
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

HEDRON Cervical Spacers is a medical device manufactured by Globus Medical, Inc.. It received FDA 510(k) clearance on 2019-09-17 under approval number K191243. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEDRON Cervical Spacers?

HEDRON Cervical Spacers is a medical device that received FDA 510(k) clearance on 2019-09-17. It is manufactured by Globus Medical, Inc.. The 510(k) number is K191243.

When was HEDRON Cervical Spacers approved by the FDA?

HEDRON Cervical Spacers received FDA 510(k) clearance on 2019-09-17, under approval number K191243.

What company makes HEDRON Cervical Spacers?

HEDRON Cervical Spacers is manufactured by Globus Medical, Inc..

What is the FDA product code for HEDRON Cervical Spacers?

The FDA product code for HEDRON Cervical Spacers is ODP.

Related Clinical Trials

NCT06938607 Post-operative Outcomes of Anterior Cervical Discectomy and Fusion Surgery With and Without Drain Placement NOT_YET_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: ODP)

K161127The Small PLATEAU (PLATEAU-C) Spacer SystemLife Spine, Inc. K162003IMSE Cervical CageThe Institute of Musculoskeletal Science & Education K160222OIC Cervical PEEK SpacerThe Orthopaedic Implant Company K161809ShurFit CpTi-HA ACIF Interbody Fusion SystemPrecision Spine, Inc. K162220DIO Medical IVA (ACIF, DLIF, PLIF, TLIF,and ALIF) CageDio Medical Co., Ltd. K161649Virtu C Spinal Implant SystemMet 1 Technologies, LLC

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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