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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 K232586
Device Name Rexious Spinal Fixation System, Statera™ Spinal System, Statera-M™ Spinal System
Applicant
K&J Consulting Corp.
2260 Glenview Dr.
Lansdale,  PA  19446
Applicant Contact Jeena Mathai
Correspondent
K&J Consulting Corp.
4027 Runnymeade Dr.
Collegeville,  PA  19426
Correspondent Contact Jeena Mathai
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
KWP   KWQ  
Date Received08/25/2023
Decision Date 10/24/2023
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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