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FDA 510(k)

HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)

K-Number: K253876 · 2025-12-22

ApplicantGlobus Medical, Inc.
Decision Date2025-12-22
Product CodeOVE
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer) is the device name listed in this FDA 510(k) record. The listed applicant is Globus Medical, Inc.. It received FDA 510(k) clearance on 2025-12-22 under 510(k) 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. The listed applicant is Globus Medical, Inc.. The 510(k) number is K253876.

When did HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer) receive FDA 510(k) clearance?

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

Who is the listed applicant for HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)?

The FDA 510(k) record lists Globus Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

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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.

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