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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name intervertebral fusion device with bone graft, lumbar
510(k) Number K160547
Device Name Cascadia Interbody System
Applicant
K2M
751 MILLER DR SE
LEESBURG,  VA  20175
Applicant Contact NANCY GIEZEN
Correspondent
K2M
751 MILLER DR SE
LEESBURG,  VA  20175
Correspondent Contact NANCY GIEZEN
Regulation Number888.3080
Classification Product Code
MAX  
Date Received02/26/2016
Decision Date 03/24/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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