FDA.reportPublic FDA data

510(k) K243843

Device
Tendon Protect (50242)
Applicant
Kerecis Limited
510(k) number
K243843
Product code
OWY
Decision
Substantially Equivalent (SESE)
Decision date
2025-06-04
Date received
2024-12-13
Regulation
878.3300
Classification name
Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon
Medical specialty
General, Plastic Surgery
Review panel
General, Plastic Surgery
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Skuli Magnusson
Address
Sundstraeti 38, 400 Isafjordur P.O. Box 151 Isafjordur IS 400 400

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code OWY#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K251690Arthrex SpeedFLEX™ ImplantArthrex, Inc.2025-09-30
K252647Tapestry Biointegrative ImplantEmbody, Inc.2025-09-19
K250109TYBR Collagen GelTybr Health2025-06-06
K242631REGENETEN™ Bioinductive ImplantSmith & Nephew Inc., Endoscopy Div.2024-11-26
K222501Regeneten Bioinductive ImplantSmith and Nephew, Inc.2023-05-11
K220867Tapestry Biointegrative ImplantEmbody, Inc.2022-05-23
K212306Tapestry Biointegrative ImplantEmbody, Inc.2021-11-02
K201572TAPESTRY Biointegrative ImplantEmbody, Inc.2020-10-19
K151083BioBridge Collagen MatrixFibralign Corporation2016-01-08
K140300COLLAGEN TENDON SHEET-DDI (CTS-DDI)Rotation Medical, Inc.2014-03-26
K133169MESO TENDON MATRIXKensey Nash Corporation Dba Dsm Biomedical2013-12-20
K131143TRELLIS COLLAGEN RIBBONWrightmedicaltechnologyinc2013-10-07
K120479MTF FASCIAMusculoskeletal Transplant Foundation2012-11-08