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510(k) K202803

Device
Activmotion S DTO
Applicant
Newclip Technics
510(k) number
K202803
Product code
HRS  
Decision
Substantially Equivalent (SESE)
Decision date
2021-12-16
Date received
2020-09-23
Regulation
888.3030
Classification name
Plate, Fixation, Bone
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Gaelle LUSSORI
Address
P.A. De La Lande Saint Martin - 45 Rue Des Garottieres Haute-Goulaine FR 44115 44115

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code HRS  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K261611TDM Large Bone Plate and Screw SystemTdm Co., Ltd.2026-10-02
K262649Alians ForearmNewclip Technics2026-09-28
K261892ProRib Fixation SystemCosta Surgical, Inc.2026-09-23
K262098EnHAnce PEEK Bunion SystemNvision Biomedical Technologies2026-09-18
K262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.2026-09-15
K261647Tempo Plating System; Ultra Compression Screw SystemPace Surgical2026-09-03
K261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See Catalog);FRAXION Mini Plate System (Various - See Catalog);FRAXION Bone Screw System (Various - See Catalog)Ortler Global Tibbi Gerecler Anonim Sirketi2026-08-28
K262537Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda.2026-08-19
K260277MIKRON TRAUMA BONE PLATE& SCREW SYSTEMMikron Makina San. ve Tic. Ltd. Sti.2026-08-13
K261511Xpert AnkleNewclip Technics2026-07-28
K261406Versalock Proximal Tibial Plating SystemGM Dos Reis Industria e Comercio Ltda.2026-07-21
K262032TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFR-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFL-SHB );TriMed Non-Spanning Wrist Fusion Plates (NSFR-SHB )TriMed, Inc.2026-07-16
K261191Alians Elbow SNewclip Technics2026-07-08
K261054RibPlate SystemStryker Leibinger GmbH & Co KG2026-07-01
K261351SALGINA 2.5mm Distal Radius SystemBonebridge AG2026-06-26

Legacy Summary#

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FDA Review#

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