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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 3 of 10| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Reamer | 1405-2400 | FDA UDI | Class I | Active |
| Chisel | 1405-2615 | FDA UDI | Class I | Active |
| Seeker-Fulcrum | 1405-2458 | FDA UDI | Class I | Active |
| Compressor & Distractor | 1405-2230 | FDA UDI | Class I | Active |
| SpeedPlate - SpeedAkin | 02-00253 | FDA UDI | Class II | Active |
| K-Wire | 1405-2018 | FDA UDI | Class I | Active |
| Half Pin | 02-00011 | FDA UDI | Class I | Active |
| Saw Blade | SN28 | FDA UDI | Class I | Active |
| K-Wire | 1405-2605 | FDA UDI | Class I | Active |
| Olive Wire | 1405-2014 | FDA UDI | Class I | Active |
| cut guide, fulcrum, seeker | 1405-2597 | FDA UDI | Class I | Active |
| K-Wire Sleeve | 02-00196 | FDA UDI | Class I | Active |
| Instrument Tray | 02-00075 | FDA UDI | Class I | Active |
| Evans Trial | 02-00315 | FDA UDI | Class I | Active |
| MIS Beveled Screw | SF3022 | FDA UDI | Class II | Active |
| Cut Guide | 1405-2081 | FDA UDI | Class I | Active |
| Osteotome | 1405-2567 | FDA UDI | Class I | Active |
| MIS Beveled Screw | SF4032 | FDA UDI | Class II | Active |
| Drill Bit | 1405-2620 | FDA UDI | Class I | Active |
| Python Plate LEFT | SD11 | FDA UDI | Class II | Active |
| Control 360 | SK12 | FDA UDI | Class II | Active |
| cut guide, fulcrum, seeker | 1405-2485 | FDA UDI | Class I | Active |
| K-Wire | 02-00124 | FDA UDI | Class I | Active |
| Lapiplasty SpeedPlate | SK50 | FDA UDI | Class II | Active |
| Lapiplasty | SK20 | FDA UDI | Class II | Active |
| Drill Bit | 1405-2619 | FDA UDI | Class I | Active |
| cut guide, fulcrum, seeker | 02-00095 | FDA UDI | Class I | Active |
| Targeting Guide | 02-00292 | FDA UDI | Class I | Active |
| AO Driver Tip | 1405-2204 | FDA UDI | Class I | Active |
| MIS Beveled Screw | SF4056 | FDA UDI | Class II | Active |
| Olive Wire | 01-1000-026 | FDA UDI | Class I | Active |
| Positioner | 1405-2036 | FDA UDI | Class I | Active |
| AO Driver Tip | 1405-2241 | FDA UDI | Class I | Active |
| Lapiplasty System 2 | SK14 | FDA UDI | Class II | Active |
| Cut Guide | 1405-2155 | FDA UDI | Class I | Active |
| Plantar Python 2 Right | SD15 | FDA UDI | Class II | Active |
| Targeter | 02-00282 | FDA UDI | Class I | Active |
| Targeting Guide | 02-00290 | FDA UDI | Class I | Active |
| Reamer | 1405-2397 | FDA UDI | Class I | Active |
| TMC PSI Cut Guide System | NK15 | FDA UDI | Class II | Active |
| Reamer | 1405-2462 | FDA UDI | Class I | Active |
| Scalpel | 02-00326 | FDA UDI | Class I | Active |
| Nanoplasty System | 02-00160 | FDA UDI | Class II | Active |
| Plantarpower Plate | SD20 | FDA UDI | Class II | Active |
| Allograft Tamp | 02-00324 | FDA UDI | Class I | Active |
| Chisel | SN38 | FDA UDI | Class I | Active |
| cut guide, fulcrum, seeker | 1405-2486 | FDA UDI | Class I | Active |
| TMC SpeedMTP | SK59 | FDA UDI | Class II | Active |
| Lapiplasty | SK26 | FDA UDI | Class II | Active |
| Tail Tack | 02-00415 | FDA UDI | Class I | Active |
Related Companies
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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. |