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FDA 510(k)

CAYMAN LP Plate System

K-Number: K190584 · 2019-05-15

ApplicantK2m, Inc.
Decision Date2019-05-15
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CAYMAN LP Plate System is a medical device manufactured by K2m, Inc.. It received FDA 510(k) clearance on 2019-05-15 under approval number K190584. 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 LP Plate System?

CAYMAN LP Plate System is a medical device that received FDA 510(k) clearance on 2019-05-15. It is manufactured by K2m, Inc.. The 510(k) number is K190584.

When was CAYMAN LP Plate System approved by the FDA?

CAYMAN LP Plate System received FDA 510(k) clearance on 2019-05-15, under approval number K190584.

What company makes CAYMAN LP Plate System?

CAYMAN LP Plate System is manufactured by K2m, Inc..

What is the FDA product code for CAYMAN LP Plate System?

The FDA product code for CAYMAN LP Plate System is KWQ.

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Official Source

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