13 results
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47ms
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Sources: EU EUDAMED, US FDA
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FDA Enforcement
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Gridlock Ankle Screw Driver Bit REF 320-35-003 - Product Usage: A screwdriver facilitates implant insertion and removal.
FDA Enforcement
Class II
·Terminated·Trilliant Surgical, LLC·January 22, 2020
3.5mm Aresenal Screw Drill Bit , Ref: 330-35-001, Qty. 70, Rx Only, Non-Sterile, UDI: (01)00812926029696 - Product Usage: A drill bit facilitates implant insertion
FDA Enforcement
Class II
·Terminated·Trilliant Surgical, LLC·May 13, 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: (1) Trilliant Surgical Tiger Cannulated Screw System, Model 210-00-001; and (2) Combination Tiger/Tiger Headless Cannulated Screw System, Model 210-00-101. The firm name on the label is Trilliant Surgical, 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: (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
8mm HTR Sterile Hammer Toe Reaming Kit, Material: Stainless Steel, Sterile: R, PX only, UDI: (01)00812926022345(17)231225 (10)TSL007202
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: (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 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