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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 K243908
Device Name Tiger 2 System
Applicant
Zavation Medical Products, LLC
3670 Flowood Drive
Flowood,  MS  39232
Applicant Contact Frankie Cummins
Correspondent
Zavation Medical Products, LLC
3670 Flowood Drive
Flowood,  MS  39232
Correspondent Contact Frankie Cummins
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
KWP   KWQ  
Date Received12/19/2024
Decision Date 02/03/2025
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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