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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 K180050
Device Name CurvaFix Intramedullary Rodscrew System
Applicant
Curvafix, Inc.
1000 124th Ave. NE
Suite 100
Bellevue,  WA  98005
Applicant Contact Steve Dimmer
Correspondent
Backroads Consulting
P.O. Box 566
Chesterland,  OH  44026
Correspondent Contact Karen E. Warden
Regulation Number888.3040
Classification Product Code
HWC  
Subsequent Product Code
HSB  
Date Received01/08/2018
Decision Date 03/01/2019
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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