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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 K241258
Device Name Ingenix Spinal System
Applicant
Ingenium Spine
1255 W. Rio Salado Pkwy.
#107
Tempe,  AZ  85281
Applicant Contact David Brumfield
Correspondent
MRC Global, LLC
9085 E. Mineral Circle,
Suite 110
Centennial,  CO  80112
Correspondent Contact Christine Scifert
Regulation Number888.3070
Classification Product Code
NKB  
Date Received05/06/2024
Decision Date 06/04/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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