510(k) K170650 ยท KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Orthofix TrueLok Hexapod System (TL-HEX) V2.0
| Applicant | Orthofix Srl, Bussolengo, IT |
| Decision | Substantially Equivalent, May 10, 2017 |
| Received | Mar 3, 2017 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K170650
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 30, 2018 | Orthofix Srl TL-HEX TruLok Hexapod System, Double Row Footplates, TL-HEX Sterile, All Sizes: 120 MM, 140 MM, 160 MM, 180 MM, 200 MM.
The TL-HEX TrueLock Hexapod System (TL-HEX) consists of rings, foot plates an Terminated |
KTT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.