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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 7 of 10| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Lapiplasty® | SD28 | FDA UDI | Class II | Active |
| Half Pin | 1405-2357 | FDA UDI | Class I | Active |
| TMC SpeedMTP | SD30 | FDA UDI | Class II | Active |
| Drill Guide | 1405-2539 | FDA UDI | Class I | Active |
| TMC SpeedMTP | 02-00266 | FDA UDI | Class II | Active |
| Driver | 1405-2188 | FDA UDI | Class I | Active |
| TMC PSI Cut Guide System | PSI-06-1032-014 | FDA UDI | Class II | Active |
| Reamer | NN14 | FDA UDI | Class I | Active |
| TMC PSI Cut Guide System | NK24 | FDA UDI | Class II | Active |
| TMC PSI Cut Guide System | NK27 | FDA UDI | Class II | Active |
| MTP Trial | 02-00337 | FDA UDI | Class I | Active |
| MIS Beveled Screw | SF4054 | FDA UDI | Class II | Active |
| Hammertoe Fixation System | SK31 | FDA UDI | Class II | Active |
| Scalpel | 1405-2555 | FDA UDI | Class I | Active |
| Osteotome | 1405-2626 | FDA UDI | Class I | Active |
| cut guide, fulcrum, seeker | 1405-2596 | FDA UDI | Class I | Active |
| Plate Tack | SN22 | FDA UDI | Class I | Active |
| Saw Blade | SN27 | FDA UDI | Class I | Active |
| K-Wire | 1405-2176 | FDA UDI | Class I | Active |
| Corner Chisel | 02-00327 | FDA UDI | Class I | Active |
| Pin Guide, Left | 01-1000-013 | FDA UDI | Class I | Active |
| MIS Beveled Screw | SF3040 | FDA UDI | Class II | Active |
| cut guide, fulcrum, seeker | 1405-2498 | FDA UDI | Class I | Active |
| MIS Beveled Screw | SF4044 | FDA UDI | Class II | Active |
| Drill Guide | 02-00255 | FDA UDI | Class I | Active |
| Cut Guide | 1405-2207 | FDA UDI | Class I | Active |
| Instrument Tray | 01-8000 | FDA UDI | Class I | Active |
| MIS Beveled Screw | SF4048 | FDA UDI | Class II | Active |
| Cut Guide | 1405-2578 | FDA UDI | Class I | Active |
| MIS Beveled Screw | SF3036 | FDA UDI | Class II | Active |
| Osteotome | 1405-2625 | FDA UDI | Class I | Active |
| Ratchet Handle | 1405-2253 | FDA UDI | Class I | Active |
| Lapiplasty | SK25 | FDA UDI | Class II | Active |
| Guide | 02-00306 | FDA UDI | Class I | Active |
| MIS Beveled Screw | SF3034 | FDA UDI | Class II | Active |
| MTP Trial | 02-00318 | FDA UDI | Class I | Active |
| TMC PSI Cut Guide System | PSI-02-00162 | FDA UDI | Class II | Active |
| Reamer | NN15 | FDA UDI | Class I | Active |
| Cut Guide | 1405-2542 | FDA UDI | Class I | Active |
| Lapiplasty Select | SK34 | FDA UDI | Class II | Active |
| SpeedMTP Compression Screws | SK60 | FDA UDI | Class II | Active |
| Seeker-Fulcrum | 1405-2459 | FDA UDI | Class I | Active |
| Drill Bit | 02-00120 | FDA UDI | Class I | Active |
| Pin | 02-00410 | FDA UDI | Class I | Active |
| K-Wire | 02-00344 | FDA UDI | Class I | Active |
| Lapiplasty SpeedPlate | 02-00183 | FDA UDI | Class II | Active |
| Cut Guide | 1405-2562 | FDA UDI | Class I | Active |
| Compressor & Distractor | 1405-2268 | FDA UDI | Class I | Active |
| Instrument Tray | 1405-2440 | FDA UDI | Class I | Active |
| Olive Wire | 1405-2218 | 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. |