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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 K230945
Device Name Forma Medical Headless Compression Screw
Applicant
Forma Medical, Inc.
3401 Hartzdale Dr., Suite 103b, Unit #611
Camp Hill,  PA  17011
Applicant Contact James A. Gault
Correspondent
Jalex Medical
27865 Clemens Rd.
Suite 3
Westlake,  OH  44145
Correspondent Contact Kyle Kovach
Regulation Number888.3040
Classification Product Code
HWC  
Date Received04/04/2023
Decision Date 07/18/2023
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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