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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Screw, Fixation, Bone
510(k) Number K230397
Device Name Cut Screw - Percutaneous Compression Screw
Applicant
GM Dos Reis Industria e Comercio Ltda.
Avenida Pierre Simon De La Pl. 600
Campinas,  BR 13069-320
Applicant Contact Guilherme Esteves Pontes
Correspondent
GM Dos Reis Industria e Comercio Ltda.
Avenida Pierre Simon De La Pl. 600
Campinas,  BR 13069-320
Correspondent Contact Guilherme Esteves Pontes
Regulation Number888.3040
Classification Product Code
HWC  
Subsequent Product Code
HRS  
Date Received02/14/2023
Decision Date 06/12/2023
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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