16 results
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32ms
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Sources: EU EUDAMED, US FDA
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Nextra CH Cannulated Hammertoe Mini Instrument Kit-indicated for small bone reconstruction limited to inter-digital repair and fusion of the lesser toes SKU: CH-MINI-KT
FDA Enforcement
Class II
·Terminated·Nextremity Solutions·March 16, 2022
Stratum Lapidus Plate - Small Rt, Part No. STRM-LAP-SMR, UDI 00817701025467. The product is part of the Stratum Foot Plating System, a plate and screws construction indicated for bone fixation.
FDA Enforcement
Class II
·Terminated·Nextremity Solutions·February 19, 2020
Stratum Foot Plating System-NL LP Screw 3.5x50mm ST, sterile. Catalog Number: STRM-NL-3550ST - Product Usage: The Stratum Foot Plating System is a plate and screws construct indicated for fixation of fractures, osteotomies, nonunions, malunions and fusions of small bones and small bone segments, particularly in osteopenic bone.
FDA Enforcement
Class II
·Terminated·Nextremity Solutions·December 4, 2019
Nextra Hammertoe Correction System-4.5MM Middle, 3.2MM Proximal, SS, Sterile. REF: NX-4532K - Product Usage: The Nextra Hammertoe Correction System is a system of implants and associated instruments which is indicated for small bone reconstruction limited to inter-digital repair and fusion of the lesser toes.
FDA Enforcement
Class II
·Terminated·Nextremity Solutions·March 18, 2020
Stratum MDS Screw 3.5x48mm ST Part Number: STRM-MDS-3548ST
FDA Enforcement
Class II
·Terminated·Nextremity Solutions·January 15, 2020
Stratum MDS Screw 3.5x50mm ST Part Number: STRM-MDS-3550ST
FDA Enforcement
Class II
·Terminated·Nextremity Solutions·January 15, 2020
Stratum MDS Screw 3.5x46mm ST Part Number: STRM-MDS-3546ST
FDA Enforcement
Class II
·Terminated·Nextremity Solutions·January 15, 2020
InCore Lapidus Disposable Kit 28mm Left, Part Number: IC-LAP-28L - Product Usage: Intended as a three-part construct intended for internal fixation for First Metatarsocuneiform arthrodesis.
FDA Enforcement
Class II
·Terminated·Nextremity Solutions·May 5, 2021
InCore Lapidus Disposable Kit 28mm Right, Part Number: IC-LAP-28R - Product Usage: Intended as a three-part construct intended for internal fixation for First Metatarsocuneiform arthrodesis.
FDA Enforcement
Class II
·Terminated·Nextremity Solutions·May 5, 2021
Nextra Cannulated Hammertoe Standard Instrument Kit-indicated for small bone reconstruction limited to inter-digital repair and fusion of the lesser toe SKU: CH-STD-KT
FDA Enforcement
Class II
·Terminated·Nextremity Solutions·March 16, 2022
Nextra Hammertoe Correction System 3.5 Middle and 3.2 Proximal Saw Cut SKU: NX-3532K-SC Orthopedic surgical instrument
FDA Enforcement
Class II
·Terminated·Nextremity Solutions·April 20, 2022
Nextra Hammertoe Correction System 3.5 Middle 3.2 Proximal Kit SKU: NX-3532K Orthopedic surgical instrument
FDA Enforcement
Class II
·Terminated·Nextremity Solutions·April 20, 2022
Nextra Hammertoe Correction System Driver SKU: NX-DR Orthopedic surgical instrument
FDA Enforcement
Class II
·Terminated·Nextremity Solutions·April 20, 2022
Nextra Hammertoe Correction System 4.5 Middle 3.2 Proximal Kit SKU: NX-4532K Orthopedic surgical instrument
FDA Enforcement
Class II
·Terminated·Nextremity Solutions·April 20, 2022
Nextra Hammertoe Correction System 4.5 Middle and 3.2 Proximal Saw Cut SKU: NX-4532K-SC Orthopedic surgical instrument
FDA Enforcement
Class II
·Terminated·Nextremity Solutions·April 20, 2022
Extremity Pack, part number AMS3240 Extremity Pack, part number AMS4764 Extremity Pack, part number AMS4788(A Extremity Pack, part number PSS1798(A Extremity Pack, part number PSS1798(A Extremity Pack, part number PSS1798(A Extremity Pack, part number PSS1842(A Extremity Pack, part number PSS1842(A Extremity Pack, part number PSS1842(A Extremity Pack, part number PSS1842(A Extremity Pack, part number PSS2706 Extremity Pack, part number PSS2706 Extremity Pack, part number PSS2706 Extremity Pack, part numbre PSS2706 Extremity Pack, part number PSS2706 Extremity Pack, part number PSS2706 Extremity Pack, part number PSS2706 Extremity Pack, part number PSS2706 Extremity Pack, part number PSS2706 Extremity Pack, part number PSS2706 Extremity Pack, part number PSS2706(A Extremity Pack, part number PSS2706(A Extremity Pack, part number PSS2706(A Extremity Pack, part number PSS2706(A
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017