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FDA 510(k)

CORRIDOR Fixation System

K-Number: K192744 · 2019-12-16

ApplicantGlobus Medical, Inc.
Decision Date2019-12-16
Product CodeMRW
DecisionSubstantially Equivalent

Device Summary

CORRIDOR Fixation System 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 2019-12-16 under 510(k) number K192744. The device is classified under product code MRW. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CORRIDOR Fixation System?

CORRIDOR Fixation System is a medical device that received FDA 510(k) clearance on 2019-12-16. The listed applicant is Globus Medical, Inc.. The 510(k) number is K192744.

When did CORRIDOR Fixation System receive FDA 510(k) clearance?

CORRIDOR Fixation System received FDA 510(k) clearance on 2019-12-16, under 510(k) number K192744.

Who is the listed applicant for CORRIDOR Fixation System?

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 CORRIDOR Fixation System?

The FDA product code for CORRIDOR Fixation System is MRW.

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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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