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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 K203228
Device Name DART-FIRE EDGE Cannulated Screw System
Applicant
Wright Medical
1023 Cherry Rd.
Memphis,  TN  38117
Applicant Contact Michael Mullins
Correspondent
Wright Medical
1023 Cherry Rd.
Memphis,  TN  38117
Correspondent Contact Michael Mullins
Regulation Number888.3040
Classification Product Code
HWC  
Date Received11/02/2020
Decision Date 05/11/2021
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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