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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Spinal Intervertebral Body
510(k) Number K190584
Device Name CAYMAN LP Plate System
Applicant
K2m,Inc.
600 Hope Pkwy. SE
Leesburg,  VA  20175
Applicant Contact Casey Hinckley
Correspondent
K2m,Inc.
600 Hope Pkwy. SE
Leesburg,  VA  20175
Correspondent Contact Casey Hinckley
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received03/06/2019
Decision Date 05/15/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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