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510(k) K140069

Device
LOCKING BONE PLATE STYLE 14, METAFIX LOCKING SCREW 3.8, MERETE CANNULATED PCS 3.0
Applicant
MERETE MEDICAL GMBH
510(k) number
K140069
Product code
HRS  
Decision
Substantially Equivalent (SESE)
Decision date
2014-04-07
Date received
2014-01-13
Regulation
888.3030
Classification name
Plate, Fixation, Bone
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
EMMANUEL ANAPLIOTIS
Address
102 Alt Lankwitz Berlin DE D-12247 D-12247

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HRS  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K263269Park's Pectus SystemTdm Co., Ltd.2026-10-15
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

Legacy Summary#

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FDA Review#

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