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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 K162264
Device Name Cascadia Interbody System
Applicant
K2m, Inc.
600 Hope Pkwy. SE
Leesburg,  VA  20175
Applicant Contact NANCY GIEZEN
Correspondent
K2m, Inc.
600 Hope Pkwy. SE
Leesburg,  VA  20175
Correspondent Contact NANCY GIEZEN
Regulation Number888.3080
Classification Product Code
MAX  
Subsequent Product Code
ODP  
Date Received08/11/2016
Decision Date 09/21/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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