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Sign in to claim this brandTREACE MEDICAL CONCEPTS, INC.
US
Last updated September 17, 2026
Information
- Country
- US
- Address
- 100 Palmetto Park Place, PONTE VEDRA, FL, 32081
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 3011623994
- DUNS Number
- —
Catalogue (493)
Page 6 of 10| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| MIS Beveled Screw | SF3018 | FDA UDI | Class II | Active |
| Pin Guide, Right | 01-1000-016 | FDA UDI | Class I | Active |
| Instrument Tray | 1405-2548 | FDA UDI | Class I | Active |
| Python Plate RIGHT | SD12 | FDA UDI | Class II | Active |
| Pin | 01-1000-002 | FDA UDI | Class I | Active |
| Cut Guide | 1405-2559 | FDA UDI | Class I | Active |
| TMC 3.0mm Long Screw Pack | SD17 | FDA UDI | Class II | Active |
| Lapiplasty SpeedPlate | 1405-2621 | FDA UDI | Class II | Active |
| Olive Wire | SN26 | FDA UDI | Class I | Active |
| Reamer | 1405-2399 | FDA UDI | Class I | Active |
| Saw Blade | 02-00341 | FDA UDI | Class I | Active |
| K-wire Sleeve | 02-00295 | FDA UDI | Class I | Active |
| MIS Beveled Screw | SF4026 | FDA UDI | Class II | Active |
| Pin Guide, Right | 01-1000-014 | FDA UDI | Class I | Active |
| AO Driver Tip | 1405-2205 | FDA UDI | Class I | Active |
| Drill Guide | 02-00114 | FDA UDI | Class I | Active |
| Lapiplasty SpeedPlate | SK46 | FDA UDI | Class II | Active |
| MIS Beveled Screw | 02-00213 | FDA UDI | Class II | Active |
| Saw Blade | 02-00274 | FDA UDI | Class I | Active |
| Cut Guide | 02-00151 | FDA UDI | Class I | Active |
| Plate Tack | 1405-2557 | FDA UDI | Class I | Active |
| MIS Beveled Screw | SF4034 | FDA UDI | Class II | Active |
| Seeker-Fulcrum | 1405-2417 | FDA UDI | Class I | Active |
| Driver | 1405-2222 | FDA UDI | Class I | Active |
| Cotton Trial | 02-00338 | FDA UDI | Class I | Active |
| Cut Guide | 1405-2552 | FDA UDI | Class I | Active |
| Cut Guide | 1405-2543 | FDA UDI | Class I | Active |
| Rotational Guide | 1405-2610 | FDA UDI | Class I | Active |
| Joint Seeker | 1405-2214 | FDA UDI | Class I | Active |
| Anatomic Model | PSI-89-1000-002 | FDA UDI | Class I | Active |
| SpeedAkin | SK63 | FDA UDI | Class II | Active |
| Guide Sleeve | 02-00100 | FDA UDI | Class I | Active |
| TMC PSI Cut Guide System | PSI-02-00163 | FDA UDI | Class II | Active |
| Positioner | 1405-2383-03 | FDA UDI | Class I | Active |
| MIS Beveled Screw | SF3050 | FDA UDI | Class II | Active |
| Drill Guide | 02-00063 | FDA UDI | Class I | Active |
| MIS Beveled Screw | SF3028 | FDA UDI | Class II | Active |
| Length Gage | 02-00203 | FDA UDI | Class I | Active |
| MIS Beveled Screw | 02-00212 | FDA UDI | Class II | Active |
| Osteotome | 02-00076 | FDA UDI | Class I | Active |
| Evans Trial | 02-00314 | FDA UDI | Class I | Active |
| Cut Guide | 1405-2586 | FDA UDI | Class I | Active |
| Lapiplasty SpeedPlate | 02-00052 | FDA UDI | Class II | Active |
| Half Pin | 1405-2516 | FDA UDI | Class I | Active |
| Drill Tack | 02-00128 | FDA UDI | Class I | Active |
| Cut Guide | 02-00289 | FDA UDI | Class I | Active |
| TMC SpeedMTP | 02-00267 | FDA UDI | Class II | Active |
| TMC PSI Cut Guide System | PSI-02-00232 | FDA UDI | Class II | Active |
| Lapiplasty SpeedPlate | SK49 | FDA UDI | Class II | Active |
| Seeker-Fulcrum | 1405-2480 | FDA UDI | Class I | Active |
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FDA Recalls (1)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Jun 2, 2024 | Z-2718-2024 | — | open, classified | Potential issue causing a higher frequency of interference with locking screws and/or inserter rods than anticipated, resulting in screws stripping and/or not fully seating in the plates and/or interface issues between inserter rods and plates. |