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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 K242827
Device Name A8 INTEGR8™ Porous Pedicle Screws
Applicant
Allumin8, Inc.
3158 W. Lakefront Ct.
Springfield,  MO  65810
Applicant Contact Alyssa Huffman
Correspondent
DuVal & Associates, P.A.
825 Nicollet Mall, Suite 1820
Medical Arts Bldg.
Minneapolis,  MN  55402
Correspondent Contact Jessica Czamanski
Regulation Number888.3070
Classification Product Code
NKB  
Date Received09/18/2024
Decision Date 10/20/2025
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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