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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, Cervical
510(k) Number K212792
Device Name Medynus IVA (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK Cage
Applicant
Medynus, Inc.
18 Technology Dr. Suite 109
Irvine,  CA  92618
Applicant Contact David Shin
Correspondent
Eerkie Corporation
4027 Runnymeade Dr.
Collegeville,  PA  19426
Correspondent Contact Jeena Mathai
Regulation Number888.3080
Classification Product Code
ODP  
Subsequent Product Code
MAX  
Date Received09/01/2021
Decision Date 09/23/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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