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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 K222397
Device Name KLS Martin Level One Rib Fixation 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 Pam Martin
Regulation Number888.3030
Classification Product Code
HRS  
Date Received08/08/2022
Decision Date 03/29/2023
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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