510(k) K081510 ยท HWC Screw, Fixation, Bone
TIGER CANNULATED SCREW SYSTEM
| Applicant | Trilliant Surgical, Ltd., Round Rock TX, US |
| Decision | Substantially Equivalent, Aug 4, 2008 |
| Received | May 29, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K081510
| 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 |
| 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 |
| 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 | None listed |
| 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 | None listed |
| Apr 26, 2010 | Trilliant Surgical LTD 2.0/2.4 Cannulated Screw Driver Bit, part #210-24-003 Terminated |
HWC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.