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FDA 510(k)

K2M COCR ROD

K-Number: K080792 · 2008-04-08

ApplicantK2m, Inc.
Decision Date2008-04-08
Product CodeMNI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

K2M COCR ROD is the device name listed in this FDA 510(k) record. The listed applicant is K2m, Inc.. It received FDA 510(k) clearance on 2008-04-08 under 510(k) number K080792. The device is classified under product code MNI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the K2M COCR ROD?

K2M COCR ROD is a medical device that received FDA 510(k) clearance on 2008-04-08. The listed applicant is K2m, Inc.. The 510(k) number is K080792.

When did K2M COCR ROD receive FDA 510(k) clearance?

K2M COCR ROD received FDA 510(k) clearance on 2008-04-08, under 510(k) number K080792.

Who is the listed applicant for K2M COCR ROD?

The FDA 510(k) record lists K2m, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for K2M COCR ROD?

The FDA product code for K2M COCR ROD is MNI.

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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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