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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
- —
- —
- —
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- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 3011623994
- DUNS Number
- —
Catalogue (493)
Page 1 of 10| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Pin Stop | 1405-2303 | FDA UDI | Class I | Active |
| cut guide, fulcrum, seeker | 02-00096 | FDA UDI | Class I | Active |
| Reamer | 1405-2022 | FDA UDI | Class I | Active |
| Lapiplasty SpeedPlate | 02-00240 | FDA UDI | Class II | Active |
| Lapiplasty Mini Incision System | SK30 | FDA UDI | Class II | Active |
| Lapiplasty SpeedPlate | 1405-2623 | FDA UDI | Class II | Active |
| MIS Beveled Screw | SF3042 | FDA UDI | Class II | Active |
| cut guide, fulcrum, seeker | 1405-2520 | FDA UDI | Class I | Active |
| TMC PSI Cut Guide System | PSI-02-00385 | FDA UDI | Class II | Active |
| Fulcrum | 1405-2142 | FDA UDI | Class I | Active |
| K-Wire | 01-1000-007 | FDA UDI | Class I | Active |
| MIS Beveled Screw | SF3048 | FDA UDI | Class II | Active |
| Lapiplasty SpeedPlate | 02-00098 | FDA UDI | Class II | Active |
| Scalpel | 02-00193 | FDA UDI | Class I | Active |
| Sizer | 02-00184 | FDA UDI | Class I | Active |
| Cut Guide | 1405-2084 | FDA UDI | Class I | Active |
| Drill Guide | 02-00136 | FDA UDI | Class I | Active |
| Incision Guide | 1405-2612 | FDA UDI | Class I | Active |
| K-Wire | 02-00026 | FDA UDI | Class I | Active |
| TMC PSI Cut Guide System | NK26 | FDA UDI | Class II | Active |
| Pin Guide, Right | 01-1000-018 | FDA UDI | Class I | Active |
| Instrument Tray | 1405-2573 | FDA UDI | Class I | Active |
| Seeker-Fulcrum | 1405-2460 | FDA UDI | Class I | Active |
| Osteotome | 1405-2607 | FDA UDI | Class I | Active |
| Cut Guide | 02-00197 | FDA UDI | Class I | Unknown |
| Nanoplasty System | 02-00169 | FDA UDI | Class II | Active |
| Drill Guide | 02-00242 | FDA UDI | Class I | Active |
| Reamer | 1405-2027 | FDA UDI | Class I | Active |
| Nanoplasty System | 02-00161 | FDA UDI | Class II | Active |
| Screwdriver | 02-00155 | FDA UDI | Class I | Active |
| Instrument Tray | 02-00147 | FDA UDI | Class I | Active |
| Reamer | 1405-2023 | FDA UDI | Class I | Active |
| Instrument Tray | 02-00127 | FDA UDI | Class I | Active |
| Pin Guide, Right | 01-1000-012 | FDA UDI | Class I | Active |
| Cross Joint Pin Guide, Left | 01-1000-005 | FDA UDI | Class I | Active |
| K-Wire | 1405-2017 | FDA UDI | Class I | Active |
| Plantar Python 2 Left | SD14 | FDA UDI | Class II | Active |
| cut guide, fulcrum, seeker | 1405-2497 | FDA UDI | Class I | Active |
| Pin Guide, Left | 01-1000-019 | FDA UDI | Class I | Active |
| Reamer | NN12 | FDA UDI | Class I | Active |
| Elevator | 02-00357 | FDA UDI | Class I | Active |
| Evans Trial | 02-00336 | FDA UDI | Class I | Active |
| MIS Beveled Screw | SF4046 | FDA UDI | Class II | Active |
| Drill Guide | 1405-2456 | FDA UDI | Class I | Active |
| Lapiplasty | SK18 | FDA UDI | Class II | Active |
| TMC PSI Cut Guide System | PSI-02-00386 | FDA UDI | Class II | Active |
| Osteotome | SN24 | FDA UDI | Class I | Active |
| K-Wire | 02-00205 | FDA UDI | Class I | Active |
| Osteotome | 02-00005 | FDA UDI | Class I | Active |
| Countersink | 1405-2227 | 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. |