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FDA 510(k)

COCR RODS

K-Number: K100788 · 2010-05-14

ApplicantGlobus Medical, Inc.
Decision Date2010-05-14
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

COCR RODS 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 2010-05-14 under 510(k) number K100788. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COCR RODS?

COCR RODS is a medical device that received FDA 510(k) clearance on 2010-05-14. The listed applicant is Globus Medical, Inc.. The 510(k) number is K100788.

When did COCR RODS receive FDA 510(k) clearance?

COCR RODS received FDA 510(k) clearance on 2010-05-14, under 510(k) number K100788.

Who is the listed applicant for COCR RODS?

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 COCR RODS?

The FDA product code for COCR RODS is NKB.

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Related Devices (Code: NKB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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