FDA.report

Product code MBI

Current FDA Classification

Device name
Fastener, Fixation, Nondegradable, Soft Tissue
Medical specialty
Orthopedic
Device class
2
Regulation number
888.3040
Review panel
OR
Implant
Y
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Eligible

Related 510(k) Records

510(k)DeviceApplicantDecision date
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
K253763Y-Knotless™ Flex AnchorsConmed Corporation2026-01-29
K260004Aevumed PROTEKT Suture AnchorAevumed, Inc.2026-01-28
K253618QuadLock™ Fixation SystemAbanza Tecnomed S.L2026-01-06
K253895Arthrex SwiveLock Suture Anchor, 3.5 x 10 mmArthrex, Inc.2025-12-30
K252596Tigon Medical Knotless and Dual Javelin All-Suture AnchorsTigon Medical2025-12-04
K252664GMReis Suture AnchorsGM Dos Reis Industria e Comercio Ltda.2025-11-04
K252314Arthrex SutureTak Suture AnchorArthrex, Inc.2025-10-29
K253040Aevumed FASE Suture AnchorAevumed, Inc.2025-10-21
K253010Mini Superhawk Suture Anchor SystemResponsive Arthroscopy, LLC2025-10-14
K250095All-Suture Dual Anchor SystemSuturetech, Inc.2025-09-05
K242895Aevumed PHANTOM Suture AnchorsAevumed, Inc.2025-08-06
K252144Iconix Speed Anchor; Iconix Speed HA+ AnchorRiverpoint Medical2025-07-30
K251310OTS 25-L (100-5)Ots Medical , Ltd.2025-07-22
K251809Arthrex FiberTak Suture AnchorArthrex, Inc.2025-07-18
K251145Arthrex PushLock Suture AnchorsArthrex, Inc.2025-07-10
K251933SnugFit ASA ExtensionMedacta International S.A.2025-07-01

Related GUDID Devices

Primary DIBrandCompanyPublished
00840277411358No-Tie ButtonRIVERPOINT MEDICAL, LLC2026-03-19
00840277405722LigaMend™ Soft Button (Blue)RIVERPOINT MEDICAL, LLC2026-03-19
00840277405715LigaMend™ Soft Button (Black)RIVERPOINT MEDICAL, LLC2026-03-19
00840277405630Strut SutureRIVERPOINT MEDICAL, LLC2026-03-19
00840277405623LigaMend™RIVERPOINT MEDICAL, LLC2026-03-19
00840277405616LigaMend™ (Blue)RIVERPOINT MEDICAL, LLC2026-03-19
00840277405609LigaMend™ (Black)RIVERPOINT MEDICAL, LLC2026-03-19
00888867550827Arthrex®ARTHREX, INC.2026-03-12
10888867550817Arthrex®ARTHREX, INC.2026-03-12
00860013967000RapidFix™ All-Suture Dual AnchorSuture Tech, Inc.2026-03-09
00888867569645Arthrex®ARTHREX, INC.2026-03-04
00888867569638Arthrex®ARTHREX, INC.2026-03-04
10886705026036TRUESPAN ORTHOCORDMedos International Sàrl2016-07-07
10886705026050TRUESPAN ORTHOCORDMedos International Sàrl2016-07-07
10886705026043TRUESPAN ORTHOCORDMedos International Sàrl2016-07-07
10886705026029TRUESPAN ORTHOCORDMedos International Sàrl2016-07-07
10886705026012TRUESPAN ORTHOCORDMedos International Sàrl2016-07-07
10886705022649RIGIDLOOPMedos International Sàrl2015-09-01
10886705024117RIGIDLOOPMedos International Sàrl2015-09-01
10886705024100RIGIDLOOPMedos International Sàrl2015-09-01
10886705024094RIGIDLOOPMedos International Sàrl2015-09-01
10886705022731RIGIDLOOPMedos International Sàrl2015-09-01
10886705022724RIGIDLOOPMedos International Sàrl2015-09-01
10886705022717RIGIDLOOPMedos International Sàrl2015-09-01
10886705022700RIGIDLOOPMedos International Sàrl2015-09-01
10886705022694RIGIDLOOPMedos International Sàrl2015-09-01
10886705022687RIGIDLOOPMedos International Sàrl2015-09-01
10886705022670RIGIDLOOPMedos International Sàrl2015-09-01
10886705022663RIGIDLOOPMedos International Sàrl2015-09-01
10886705022656RIGIDLOOPMedos International Sàrl2015-09-01