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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 K223654
Device Name Medussa-PL Cage
Applicant
Medyssey USA, Inc.
1302 Busch Pkwy.
Buffalo Grove,  IL  60089
Applicant Contact Youngsu Jang
Correspondent
Eerkie Corp
4027 Runnymeade Dr.
Collegeville,  PA  19426
Correspondent Contact Jeena Mathai
Regulation Number888.3080
Classification Product Code
MAX  
Date Received12/06/2022
Decision Date 12/28/2022
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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