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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 K183407
Device Name Triton Cage
Applicant
Medyssey USA, Inc.
1550 E. Higgins Road, Suite 123
Elk Grove Village,  IL  60007
Applicant Contact Shawn Kim
Correspondent
Musculoskeletal Clinical Regulatory Advisers, LLC
1050 K Street NW, Suite 1000
Washington,  DC  20001
Correspondent Contact Justin Eggleton
Regulation Number888.3080
Classification Product Code
MAX  
Date Received12/10/2018
Decision Date 08/30/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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