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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Facet Screw Spinal Device
510(k) Number K232877
Device Name FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous Fixation System, and AEON-C™ Stand Alone System
Applicant
K&J Consulting Corporation
2260 Glenview Dr.
Lansdale,  PA  19446
Applicant Contact Milan George
Correspondent
Eerkie Corporation
4027 Runnymeade Dr.
Collegeville,  PA  19426
Correspondent Contact Jeena Mathai
Classification Product Code
MRW  
Subsequent Product Codes
HWC   ODP   OUR   OVE   PEK  
Date Received09/15/2023
Decision Date 12/13/2023
Decision Substantially Equivalent (SESE)
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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