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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 K193203
Device Name MOJAVE Expandable Interbody System
Applicant
K2m, Inc.
600 Hope Pkwy. SE
Leesburg,  VA  21075
Applicant Contact Oonagh Lahiff
Correspondent
Stryker
2 Pearl Ct.
Allendale,  NJ  07401
Correspondent Contact Megan Callanan
Regulation Number888.3080
Classification Product Code
MAX  
Date Received11/20/2019
Decision Date 02/18/2020
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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