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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Screw, Fixation, Bone
510(k) Number K252019
Device Name CurvaFix Low Profile System
Applicant
Curvafix, Inc.
1406 140th Pl. NE
Suite 107
Bellevue,  WA  98007
Applicant Contact Mark Foster
Correspondent
DuVal & Associates, P.A.
825 Nicollet Mall, Suite 1820
Medical Arts Bldg.
Minneapolis,  MN  55402
Correspondent Contact Lisa L. Pritchard
Regulation Number888.3040
Classification Product Code
HWC  
Subsequent Product Code
HTN  
Date Received06/30/2025
Decision Date 08/29/2025
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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