510(k) K160177 ยท HRS Plate, Fixation, Bone
Gridlock Ankle Plating System
| Applicant | Trilliant Surgical, Ltd., Houston TX, US |
| Decision | Substantially Equivalent, Apr 22, 2016 |
| Received | Jan 27, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K160177
| 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 Ankle Plating System, Model 320-01-100. The firm name on the label is Trilliant Surgical Ltd, Terminated |
HWC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.