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FDA 510(k)

K2M COCR WIRE

K-Number: K103797 · 2011-05-20

ApplicantK2m, Inc.
Decision Date2011-05-20
Product CodeJDQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

K2M COCR WIRE is the device name listed in this FDA 510(k) record. The listed applicant is K2m, Inc.. It received FDA 510(k) clearance on 2011-05-20 under 510(k) number K103797. The device is classified under product code JDQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the K2M COCR WIRE?

K2M COCR WIRE is a medical device that received FDA 510(k) clearance on 2011-05-20. The listed applicant is K2m, Inc.. The 510(k) number is K103797.

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

K2M COCR WIRE received FDA 510(k) clearance on 2011-05-20, under 510(k) number K103797.

Who is the listed applicant for K2M COCR WIRE?

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 WIRE?

The FDA product code for K2M COCR WIRE is JDQ.

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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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