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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 K261002
Device Name Pectus Blu System
Applicant
Biomet Microfixation
1520 Tradeport Dr.
Jacksonville,  FL  32218
Applicant Contact Jose Ponce
Correspondent
MRC Global, LLC
9160 Hwy. 64, Suite 12
P.O. Box 330
Lakeland,  TN  38002
Correspondent Contact Danielle Besal
Regulation Number888.3030
Classification Product Code
HRS  
Date Received03/26/2026
Decision Date 06/02/2026
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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