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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 K230053
Device Name SimpliFix Hip System
Applicant
Stabiliz Orthopaedics, Inc.
600 Eagleview Blvd.
Unit 300
Exton,  PA  19341
Applicant Contact Douglas Cerynik
Correspondent
Mcra, LLC
803 7th St. NW, 3rd Floor
Washington,  DC  20000
Correspondent Contact Hollace S. Rhodes
Regulation Number888.3040
Classification Product Code
HWC  
Date Received01/06/2023
Decision Date 04/19/2023
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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