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FDA 510(k)

HEDRON Lumbar Spacers

K-Number: K191391 · 2019-09-18

ApplicantGlobus Medical, Inc.
Decision Date2019-09-18
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

HEDRON Lumbar Spacers 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 2019-09-18 under 510(k) number K191391. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEDRON Lumbar Spacers?

HEDRON Lumbar Spacers is a medical device that received FDA 510(k) clearance on 2019-09-18. The listed applicant is Globus Medical, Inc.. The 510(k) number is K191391.

When did HEDRON Lumbar Spacers receive FDA 510(k) clearance?

HEDRON Lumbar Spacers received FDA 510(k) clearance on 2019-09-18, under 510(k) number K191391.

Who is the listed applicant for HEDRON Lumbar Spacers?

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 Lumbar Spacers?

The FDA product code for HEDRON Lumbar Spacers is MAX.

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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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