Trilliant Surgical, Ltd.
Trilliant Surgical, Ltd. holds FDA 510(k) medical device clearances, first cleared 2007, most recent 2017, with 10 FDA device recalls on record.
Top product codes for Trilliant Surgical, Ltd.
FDA recalls by Trilliant Surgical, Ltd.
- Z-2339-2018 — Ratcheting Cannulated Driver Handle, Catalog #: 210-00-004, Rx Only, Non Sterile
- Z-2338-2018 — Cannulated Driver Handle, Catalog #: 210-00-003, Rx Only, Non Sterile
- Z-0960-2017 — 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.
- Z-0609-2017 — 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"
- Z-2490-2015 — 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.
- Z-2738-2015 — 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.
- Z-2421-2015 — 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.
- Z-2464-2015 — 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.
- Z-2456-2015 — 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.
- Z-2452-2015 — 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.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Trilliant Surgical, Ltd.
- K172178 — Minimally Invasive Bunion Plating System
- K162354 — Sniper Staple System
- K160177 — Gridlock Ankle Plating System
- K153338 — Tiger Cannulated Screw System
- K130964 — GRIDLOCK PLATING SYSTEM
- K123525 — GRIDLOCK PLATING SYSTEM
- K122959 — HAMMER TOE IMPLANT
- K121452 — GRIDLOCK PLATING SYSTEM
- K121008 — TRILLIANT SURGICAL K-WIRES
- K111834 — DISCO SUBTALAR IMPLANT
- K112737 — TIGER HEADLESS CANNULATED SCREWS
- K103183 — TRILLIANT SURGICAL SUBTALAR IMPLANT
- K081510 — TIGER CANNULATED SCREW SYSTEM
- K072922 — 3S HEMI TOE
Data sourced from openFDA. This site is unofficial and independent of the FDA.