FDA.reportPublic FDA data

510(k) K222423

Device
Fixone All Suture Anchor
Applicant
Aju Pharm Co., Ltd.
510(k) number
K222423
Product code
MBI
Decision
Substantially Equivalent (SESE)
Decision date
2023-03-23
Date received
2022-08-11
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
Gun Tak Lee
Address
A-207, 697, Pangyo-Ro Seongnam-Si KR 13511 13511

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
K261632Thunderbolt SystemResponsive Arthroscopy, Inc.2026-07-20
K261968Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE suture (72205981); Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one blue knotless and one black MINITAPE suture (72205982)Smith & Nephew, Inc.2026-07-09
K260018Arthrex FiberButtonArthrex, Inc.2026-06-26
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