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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Posterior Cervical Screw System
510(k) Number K233332
Device Name Statera-C™ Spinal System
Applicant
K&J Consulting Corp.
2260 Glenview Dr.
Lansdale,  PA  19446
Applicant Contact Milan George
Correspondent
Eerkie Corporation
4027 Runnymeade Dr.
Collegeville,  PA  19426
Correspondent Contact Jeena Mathai
Regulation Number888.3075
Classification Product Code
NKG  
Subsequent Product Code
KWP  
Date Received09/29/2023
Decision Date 11/27/2023
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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