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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 9 of 10| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Lapiplasty SpeedPlate - MicroQuad | SK62 | FDA UDI | Class II | Active |
| MIS Beveled Screw | SF3030 | FDA UDI | Class II | Active |
| Reamer | NN19 | FDA UDI | Class I | Active |
| K-Wire | 02-00201 | FDA UDI | Class I | Active |
| Olive Wire | 1405-2266 | FDA UDI | Class I | Active |
| Retraction Drill Guide | 02-00125 | FDA UDI | Class I | Active |
| Drill Guide | 1405-2455 | FDA UDI | Class I | Active |
| MIS Beveled Screw | SF4064 | FDA UDI | Class II | Active |
| Cotton Trial | 02-00321 | FDA UDI | Class I | Active |
| Osteotome | SN21 | FDA UDI | Class I | Active |
| Instrument Tray | 02-00347 | FDA UDI | Class I | Active |
| Drill | 01-1000-028 | FDA UDI | Class I | Active |
| MIS Beveled Screw | SF4038 | FDA UDI | Class II | Active |
| Plate Tack | 1405-2582 | FDA UDI | Class I | Active |
| Reamer | 1405-2024 | FDA UDI | Class I | Active |
| AO Driver Tip | 1405-2215 | FDA UDI | Class I | Active |
| MIS Beveled Screw | SF4024 | FDA UDI | Class II | Active |
| Pin Guide, Right | 01-1000-020 | FDA UDI | Class I | Active |
| K-Wire | 1405-2041 | FDA UDI | Class I | Active |
| Positioner | 1405-2383-02 | FDA UDI | Class I | Active |
| Pin Guide, Right | 01-1000-022 | FDA UDI | Class I | Active |
| AO Driver Tip | 02-00214 | FDA UDI | Class I | Active |
| Instrument Tray | 02-00247 | FDA UDI | Class I | Active |
| Drill Guide | 1405-2587 | FDA UDI | Class I | Active |
| MIS Beveled Screw | SF4042 | FDA UDI | Class II | Active |
| TMC SpeedMTP | SK58 | FDA UDI | Class II | Active |
| Compressor / Distractor | 01-1000-003 | FDA UDI | Class I | Active |
| TMC PSI Cut Guide System | PSI-02-00231 | FDA UDI | Class II | Active |
| K-Wire | 02-00300 | FDA UDI | Class I | Active |
| Cut Guide | 1405-2137 | FDA UDI | Class I | Active |
| MIS Beveled Screw | SF3046 | FDA UDI | Class II | Active |
| Drill Bit | 1405-2432 | FDA UDI | Class I | Active |
| Screwdriver | 1405-2127 | FDA UDI | Class I | Active |
| Drill Guide | 02-00060 | FDA UDI | Class I | Active |
| Gage | 02-00371 | FDA UDI | Class I | Active |
| Drill | 02-00150 | FDA UDI | Class I | Active |
| K-Wire | 1405-2593 | FDA UDI | Class I | Active |
| Lapiplasty SpeedPlate - MicroQuad | SK61 | FDA UDI | Class II | Active |
| Lapiplasty SpeedPlate | 02-00101 | FDA UDI | Class II | Active |
| Depth gauge countersink | 02-00246 | FDA UDI | Class I | Active |
| Drill Guide | 02-00177 | FDA UDI | Class I | Active |
| Pin Guide, Left | 01-1000-021 | FDA UDI | Class I | Active |
| Countersink | 1405-2229 | FDA UDI | Class I | Active |
| Nanoplasty System | 02-00199 | FDA UDI | Class II | Active |
| Cut Guide | 1405-2541 | FDA UDI | Class I | Active |
| Fastgrafter | SK27 | FDA UDI | Class I | Active |
| Drill Guide | 02-00104 | FDA UDI | Class I | Active |
| Retractor | 1405-2627 | FDA UDI | Class I | Active |
| Lapiplasty System 3R | SK23 | FDA UDI | Class II | Active |
| Pin | 02-00332 | 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. |