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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Thoracolumbosacral Pedicle Screw System
510(k) Number K210420
Device Name Goblin and Goblin LS Pedicle Screw Systems
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 Number888.3070
Classification Product Code
NKB  
Date Received02/11/2021
Decision Date 04/19/2021
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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