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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 K253660
Device Name KLS Martin Pure Pectus 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 Meraj Akhtar
Regulation Number888.3030
Classification Product Code
HRS  
Date Received11/20/2025
Decision Date 02/20/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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