510(k) K112737 ยท HWC Screw, Fixation, Bone
TIGER HEADLESS CANNULATED SCREWS
| Applicant | Trilliant Surgical, Ltd., Round Rock TX, US |
| Decision | Substantially Equivalent, Oct 20, 2011 |
| Received | Sep 20, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K112737
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.