BEUDAMED
    19 results · 36ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii ×

    Instructions for Use and Surgical Cleaning and Sterilization Protocol for: (1) Trilliant Surgical Ltd Tiger Large Cannulated Screw System, Model 215-00-001; and (2) Trilliant Surgical Ltd Large Cannulated Headless Screw System, Model 215-00-001. The firm name on the label is Trilliant Surgical Ltd., Houston, TX.

    FDA Enforcement
    Class II ·Terminated·Trilliant Surgical, LLC·April 8, 2020

    Instructions for Use and Surgical Cleaning and Sterilization Protocol for Trilliant Surgical Ltd Gridlock Plating System, Model 310-01-100. The firm name on the label is Trilliant Surgical Ltd, Houston, TX.

    FDA Enforcement
    Class II ·Terminated·Trilliant Surgical, LLC·April 8, 2020

    Instructions for Use and Surgical Cleaning and Sterilization Protocol for Trilliant Surgical Ltd 3S Hemi Toe Implant System, Model 111-00-001. The firm name on the label is Trilliant Surgical Ltd, Houston, TX.

    FDA Enforcement
    Class II ·Terminated·Trilliant Surgical, LLC·April 8, 2020

    Instructions for Use and Surgical Cleaning and Sterilization Protocol for Trilliant Surgical Ltd Gridlock Ankle Plating System, Model 320-01-100. The firm name on the label is Trilliant Surgical Ltd, Houston, TX.

    FDA Enforcement
    Class II ·Terminated·Trilliant Surgical, LLC·April 8, 2020

    Instructions for Use and Surgical Cleaning and Sterilization Protocol for Trilliant Surgical Ltd Small Joint Reaming System, Model 311-00-001. The firm name on the label is Trilliant Surgical Ltd, Houston, TX.

    FDA Enforcement
    Class II ·Terminated·Trilliant Surgical, LLC·April 8, 2020

    Instructions for Use and Surgical Cleaning and Sterilization Protocol for Trilliant Surgical Ltd Two-Step Hammertoe Implant System, Model 214-00-001. The firm name on the label is Trilliant Surgical Ltd, Houston, TX.

    FDA Enforcement
    Class II ·Terminated·Trilliant Surgical, LLC·April 8, 2020

    Instructions for Use and Surgical Cleaning and Sterilization Protocol for Trilliant Surgical Ltd Disco Subtalar Implant System, Model 112-00-001. The firm name on the label is Trilliant Surgical, Ltd, Houston, TX.

    FDA Enforcement
    Class II ·Terminated·Trilliant Surgical, LLC·April 8, 2020

    Instructions for Use and Surgical Cleaning Sterilization Protocol for Trilliant Surgical Ltd Twist Sublatar Implant System, Model 112-00-001. The firm name on the label is Trilliant Surgical, Ltd, Houston, TX.

    FDA Enforcement
    Class II ·Terminated·Trilliant Surgical, LLC·April 8, 2020

    Instructions for Use and Surgical Cleaning and Sterilization Protocol for: (1) Trilliant Surgical Ltd Tiger Headless Cannulated Screw System, Model 212-00-001; and (2) Combination Tiger Cannulated/Tiger Headless Cannulated Screw System, Model 210-00-101. The firm name on the label is Trilliant Surgical Ltd, Houston, TX.

    FDA Enforcement
    Class II ·Terminated·Trilliant Surgical, LLC·April 8, 2020

    Model 208-70-110, Long Thread Tiger Large Cannulated Headless Screw, 7 x 110 mm labeled as "7.0 x 110mm LTTHCS REF 208-70-110 QTY 30 LOT TSL003721 2016-03-29 Trilliant Surgical, LTD"

    FDA Enforcement
    Class II ·Terminated·Trilliant Surgical Ltd.·November 23, 2016

    Ratcheting Cannulated Driver Handle, Catalog #: 210-00-004, Rx Only, Non Sterile

    FDA Enforcement
    Class II ·Terminated·Trilliant Surgical Ltd.·July 11, 2018

    Cannulated Driver Handle, Catalog #: 210-00-003, Rx Only, Non Sterile

    FDA Enforcement
    Class II ·Terminated·Trilliant Surgical Ltd.·July 11, 2018

    Tiger Screw Sterilization Tray Base Assembly Model 210-00-001 Revision N, O The product is a component of a system indicated for the fixation of fractures, non-unions, arthrodeses, and osteotomies of bones appropriate for the size of the device.

    FDA Enforcement
    Class II ·Terminated·Trilliant Surgical Ltd.·January 18, 2017

    2.0/2.4 Cannulated Screw Countersink Part # 210-24-002 NON-STERILE and 3.0/4.0 Cannulated Screw Countersink Part # 210-40-002 NON-STERILE Product Usage: The Tiger Cannulated Screw Fixation System implants are intended for fixation of fractures, non-unions, arthrodesis, and osteotomies of the small bones in the hand and foot. The implants and guide wires are intended for single use only.

    FDA Enforcement
    Class II ·Terminated·Trilliant Surgical Ltd.·August 26, 2015

    Tiger Cannulated Tray Lid Part # 210-00-001-1 NON-STERILE; Combined Tiger/Headless Screw Part # 210-99-101 NON-STERILE; These are components of the Tiger Cannulated Screw System and the Tiger Headless Cannulated Screw System The Tiger Cannulated Screw Fixation System and the Tiger Headless Cannulated Screw Fixation System implants are intended for fixation of fractures, non-unions, arthrodesis and osteotomies of the small bones in the hand and foot. The implants and guide wires are intended for single use only.

    FDA Enforcement
    Class II ·Terminated·Trilliant Surgical Ltd.·September 2, 2015

    Concave Reamer Head, 16 mm; Concave Reamer Head, 18 mm; Concave Reamer Head, 20 mm; Concave Reamer Head 22 mm; Convex Reamer Head, 16 mm; Convex Reamer Head, 18 mm; Convex Reamer Head 20 mm; Convex Reamer Head 22 mm, used with Gridlock Plating system, for use in trauma and reconstructive procedures in small bones.

    FDA Enforcement
    Class II ·Terminated·Trilliant Surgical Ltd.·September 2, 2015

    3.0/4.0 Cannulated Drill Bit; a component of the Tiger Cannulated Screw System The Tiger Cannulated Screw Fixation System implants are intended for fixation of fractures, non-unions, arthrodesis and osteotomies of the small bones in the hand and foot. The implants and guide wires are intended for single use only.

    FDA Enforcement
    Class II ·Terminated·Trilliant Surgical Ltd.·September 2, 2015

    7 Hole VL Gridlock Fibula Plate, Part # 300-60-001 NON-STERILE SINGLE USE ONLY; 9 Hole VL Gridlock Fibula Plate, Part # 300-60-002 NON-STERILE SINGLE USE ONLY; 11 Hole VL Gridlock Fibula Plate, Part # 300-60-003 NON-STERILE SINGLE USE ONLY. For use in trauma and reconstructive procedures in small bones.

    FDA Enforcement
    Class II ·Terminated·Trilliant Surgical Ltd.·September 9, 2015

    2.4, 3.0, and 4.0 mm Gridlock Screw Driver Bit, Model Number 310-30-003, Lot Number TSL002605, NON-STERILE. For use with the Gridlock Plating System for trauma and reconstructive procedures of small bones.

    FDA Enforcement
    Class II ·Terminated·Trilliant Surgical Ltd.·September 16, 2015