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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 K261892
Device Name ProRib Fixation System
Applicant
Costa Surgical, Inc.
3225 N. Colorado St.
Chandler,  AZ  85225
Applicant Contact Nick Slater
Correspondent
Costa Surgical, Inc.
3225 N. Colorado St.
Chandler,  AZ  85225
Correspondent Contact Nick Slater
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Codes
HTN   HWC  
Date Received06/05/2026
Decision Date 09/23/2026
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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