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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 K250536
Device Name MetaFore Small Screw System
Applicant
Extremity Medical, LLC
300 Interpace Pkwy.
Bldg. A, 2nd Floor
Parsippany,  NJ  07054
Applicant Contact Mary Hoffman
Correspondent
Extremity Medical, LLC
300 Interpace Pkwy.
Bldg. A, 2nd Floor
Parsippany,  NJ  07054
Correspondent Contact Mary Hoffman
Regulation Number888.3040
Classification Product Code
HWC  
Date Received02/24/2025
Decision Date 10/08/2025
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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