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FDA 510(k)

CAYMAN MI PLATE SYSTEM

K-Number: K131533 · 2013-11-09

ApplicantK2m, Inc.
Decision Date2013-11-09
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CAYMAN MI PLATE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is K2m, Inc.. It received FDA 510(k) clearance on 2013-11-09 under 510(k) number K131533. The device is classified under product code KWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CAYMAN MI PLATE SYSTEM?

CAYMAN MI PLATE SYSTEM is a medical device that received FDA 510(k) clearance on 2013-11-09. The listed applicant is K2m, Inc.. The 510(k) number is K131533.

When did CAYMAN MI PLATE SYSTEM receive FDA 510(k) clearance?

CAYMAN MI PLATE SYSTEM received FDA 510(k) clearance on 2013-11-09, under 510(k) number K131533.

Who is the listed applicant for CAYMAN MI PLATE SYSTEM?

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 CAYMAN MI PLATE SYSTEM?

The FDA product code for CAYMAN MI PLATE SYSTEM is KWQ.

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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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