Company ยท US
Trilliant Surgical, Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 2007 to 2022. Name variants (Inc, Corp, punctuation) are merged.
18510(k) clearances (0 in 12 months)
24recalls (0 in 12 months)
19recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 23, 2022 | K212378 | Arsenal Ankle Plating System Trilliant Surgical | HRS |
| Aug 12, 2019 | K191009 | Arsenal Plating System Trilliant Surgical | HRS |
| Oct 26, 2018 | K181898 | Two-Step Implant System Trilliant Surgical | HWC |
| Dec 11, 2017 | K172405 | SNIPER STAPLE SYSTEM, NON-STERILE Trilliant Surgical | JDR |
| Nov 16, 2017 | K172178 | Minimally Invasive Bunion Plating System Trilliant Surgical, Ltd. | HRS |
| Apr 20, 2017 | K162354 | Sniper Staple System Trilliant Surgical, Ltd. | JDR |
| Apr 22, 2016 | K160177 | Gridlock Ankle Plating System Trilliant Surgical, Ltd. | HRS |
| Jan 14, 2016 | K153338 | Tiger Cannulated Screw System Trilliant Surgical, Ltd. | HWC |
| May 8, 2013 | K130964 | GRIDLOCK PLATING SYSTEM Trilliant Surgical, Ltd. | HRS |
| Feb 15, 2013 | K123525 | GRIDLOCK PLATING SYSTEM Trilliant Surgical, Ltd. | HRS |
| Nov 7, 2012 | K122959 | HAMMER TOE IMPLANT Trilliant Surgical, Ltd. | HWC |
| Aug 20, 2012 | K121452 | GRIDLOCK PLATING SYSTEM Trilliant Surgical, Ltd. | HRS |
| Jun 4, 2012 | K121008 | TRILLIANT SURGICAL K-WIRES Trilliant Surgical, Ltd. | HTY |
| Dec 6, 2011 | K111834 | DISCO SUBTALAR IMPLANT Trilliant Surgical, Ltd. | HWC |
| Oct 20, 2011 | K112737 | TIGER HEADLESS CANNULATED SCREWS Trilliant Surgical, Ltd. | HWC |
| Feb 8, 2011 | K103183 | TRILLIANT SURGICAL SUBTALAR IMPLANT Trilliant Surgical, Ltd. | HWC |
| Aug 4, 2008 | K081510 | TIGER CANNULATED SCREW SYSTEM Trilliant Surgical, Ltd. | HWC |
| Nov 28, 2007 | K072922 | 3S HEMI TOE Trilliant Surgical, Ltd. | KWD |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 1, 2020 | Trilliant Surgical, LLC 8mm HTR Sterile Hammer Toe Reaming Kit, Material: Stainless Steel, Sterile: R, PX only, UDI: (01)00812926022345(17)231225
(10)TSL007202 Terminated |
HTY | K121008 |
| Oct 10, 2019 | Trilliant Surgical, LLC 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 Terminated |
HTW | None listed |
| Mar 14, 2019 | Trilliant Surgical, LLC Gridlock Ankle Screw Driver Bit REF 320-35-003 - Product Usage: A screwdriver facilitates implant insertion and removal. Terminated |
HXX | None listed |
| Jul 19, 2018 | Trilliant Surgical, LLC 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, Ho Terminated |
HWC | None listed |
| Jul 19, 2018 | Trilliant Surgical, LLC 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, Terminated |
HWC | K160177 |
| Jul 19, 2018 | Trilliant Surgical, LLC 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 Cann Terminated |
HWC | K153338 |
| Jul 19, 2018 | Trilliant Surgical, LLC 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, H Terminated |
HWC | K072922 |
| Jul 19, 2018 | Trilliant Surgical, LLC 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 Terminated |
HWC | K122959 |
| Jul 19, 2018 | Trilliant Surgical, LLC 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, Houst Terminated |
HWC | K121452 K123525 +1 |
| Jul 19, 2018 | Trilliant Surgical, LLC 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 Terminated |
HWC | K111834 |
| Jul 19, 2018 | Trilliant Surgical, LLC 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, Ho Terminated |
HWC | K103183 |
| Jul 19, 2018 | Trilliant Surgical, LLC 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/T Terminated |
HWC | K112737 K153338 |
| Jul 19, 2018 | Trilliant Surgical, LLC 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 Terminated |
HWC | K081510 K112737 +1 |
| Mar 27, 2018 | Trilliant Surgical Ltd. Ratcheting Cannulated Driver Handle, Catalog #: 210-00-004, Rx Only, Non Sterile Terminated |
MDM | None listed |
| Mar 27, 2018 | Trilliant Surgical Ltd. Cannulated Driver Handle, Catalog #: 210-00-003, Rx Only, Non Sterile Terminated |
MDM | None listed |
| Jan 6, 2017 | Trilliant Surgical Ltd. 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 Terminated |
HWC | K153338 |
| Nov 17, 2016 | Trilliant Surgical Ltd. 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" Terminated |
HWC | K112737 |
| Sep 4, 2015 | Trilliant Surgical Ltd. 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 Terminated |
HRS | K121452 |
| Aug 31, 2015 | Trilliant Surgical Ltd. 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 # Terminated |
HRS | K121452 |
| Aug 26, 2015 | Trilliant Surgical Ltd. 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 Terminated |
HWC | K081510 K112737 |
| Aug 24, 2015 | Trilliant Surgical Ltd. 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 Re Terminated |
HTO | K121452 |
| Aug 24, 2015 | Trilliant Surgical Ltd. 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 o Terminated |
HTW | K081510 |
| Aug 19, 2015 | Trilliant Surgical Ltd. 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 i Terminated |
HWC | K081510 |
| Apr 26, 2010 | Trilliant Surgical LTD 2.0/2.4 Cannulated Screw Driver Bit, part #210-24-003 Terminated |
HWC | K081510 |