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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Fixation, Bone
510(k) Number K250865
Device Name KLS Martin IPS Forearm System
Applicant
KLS-Martin L.P.
11201 Saint Johns Industrial Pkwy. S.
Jacksonville,  FL  32246
Applicant Contact Melissa Bachorski
Correspondent
KLS-Martin L.P.
11201 Saint Johns Industrial Pkwy. S.
Jacksonville,  FL  32246
Correspondent Contact Liza Gordillo
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Codes
HWC   PBF  
Date Received03/21/2025
Decision Date 11/14/2025
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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