510(k) K121452 ยท HRS Plate, Fixation, Bone
GRIDLOCK PLATING SYSTEM
| Applicant | Trilliant Surgical, Ltd., Round Rock TX, US |
| Decision | Substantially Equivalent, Aug 20, 2012 |
| Received | May 16, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K121452
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.