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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name fastener, fixation, biodegradable, soft tissue
510(k) Number K170868
Device Name FIXIT Threaded Anchor System
Applicant
S.B.M SAS Science for Bio Materials
ZI du Monge
Lourdes,  FR 65100
Applicant Contact Anne Cospin-Latapie
Correspondent
S.B.M SAS Science for Bio Materials
ZI du Monge
Lourdes,  FR 65100
Correspondent Contact Anne Cospin-Latapie
Regulation Number888.3030
Classification Product Code
MAI  
Date Received03/23/2017
Decision Date 11/30/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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