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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, nondegradable, soft tissue
510(k) Number K202193
Device Name PULLUP BTB Adjustable Fixation System for Ligament Reconstruction, PULLUP CLIP Adjustable Fixation System for Ligament Reconstruction, PULLUP TEX CLIP Adjustable Fixation System for Ligament Reconstruction, BT LOOP Adjustable Fixation System for Ligament Reconstruction
Applicant
S.B.M. SAS (Science & Bio Materials)
Zi Du Monge
Lourdes,  FR 65100
Applicant Contact Anne Cospin-Latapie
Correspondent
S.B.M. SAS (Science & Bio Materials)
Zi Du Monge
Lourdes,  FR 65100
Correspondent Contact Anne Cospin-Latapie
Regulation Number888.3040
Classification Product Code
MBI  
Date Received08/05/2020
Decision Date 10/16/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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