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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 K253943
Device Name Tiger 2 System
Applicant
Zavation Medical Products, LLC
3670 Flowood Dr.
Flowood,  MS  39232
Applicant Contact Frankie Cummins
Correspondent
Zavation Medical Products, LLC
3670 Flowood Dr.
Flowood,  MS  39232
Correspondent Contact Frankie Cummins
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
KWP   KWQ   PML  
Date Received12/10/2025
Decision Date 07/24/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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