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510(k) K202193

Device
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 Liga
Applicant
S.B.M. SAS (Science & Bio Materials)
510(k) number
K202193
Product code
MBI  
Decision
Substantially Equivalent (SESE)
Decision date
2020-10-16
Date received
2020-08-05
Regulation
888.3040
Classification name
Fastener, Fixation, Nondegradable, Soft Tissue
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Anne Cospin-Latapie
Address
Zi Du Monge Lourdes FR 65100 65100

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MBI  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K253130Dione PEEK Screw SystemZheJiang Decans Medical Devices Co., Ltd.2026-05-27
K261363Y-Knotless™ Flex AnchorsCONMED Corporation2026-05-13
K253027Anchor with Fiber Wire and Disposable InserterOrtobio S.A.2026-05-06
K252635ArthroTAK Tendon Anchor KitArthroTAK, LLC2026-05-01
K260921Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor LineTigon Medical2026-04-21
K260561Arthrex FiberTak Suture AnchorArthrex, Inc.2026-03-20
K253886Grappler Suture Anchor PCFD Tether SystemParagon 28, Inc.2026-03-17
K254176SINEFIXBAAT Medical Products B.V.2026-03-16
K251750Trax EX AnchorTrax Surgical, Inc.2026-03-12
K253693Strut Suture; No-Tie ButtonRiverpoint Medical, LLC2026-03-11
K260405FiberTape ButtonArthrex, Inc.2026-03-09
K253538TeKBrace Knotless AnchorTheramicro2026-03-06
K254306Aevumed FENIX Suture AnchorAevumed, Inc.2026-03-04
K254229Arthrex Nano FiberTak Suture AnchorArthrex, Inc.2026-03-02
K253695LigaMendRiverpoint Medical, LLC2026-02-27

Legacy Summary#

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FDA Review#

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