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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 5 of 10| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Fastpitch | SD22 | FDA UDI | Class II | Active |
| Compressor / Distractor | 01-1000-027 | FDA UDI | Class I | Active |
| cut guide, fulcrum, seeker | 1405-2499 | FDA UDI | Class I | Active |
| Cut Guide | 1405-2080 | FDA UDI | Class I | Active |
| Pin Guide, Left | 01-1000-015 | FDA UDI | Class I | Active |
| MIS Beveled Screw | SF4052 | FDA UDI | Class II | Active |
| Nanoplasty System | SK57 | FDA UDI | Class II | Active |
| AO Driver Tip | 1405-2202 | FDA UDI | Class I | Active |
| Osteotome | 02-00077 | FDA UDI | Class I | Active |
| TMC PSI Cut Guide System | PSI-02-00233 | FDA UDI | Class II | Active |
| Drill Guide | 02-00273 | FDA UDI | Class I | Active |
| Saw Blade | SN31 | FDA UDI | Class I | Active |
| Targeter | 02-00285 | FDA UDI | Class I | Active |
| Scalpel | SN20 | FDA UDI | Class I | Active |
| MIS Beveled Screw | SF4058 | FDA UDI | Class II | Active |
| Bender | 1405-2200 | FDA UDI | Class I | Active |
| K-Wire | 1405-2515 | FDA UDI | Class I | Active |
| cut guide, fulcrum, seeker | 1405-2496 | FDA UDI | Class I | Active |
| Lapiplasty SpeedPlate | SK51 | FDA UDI | Class II | Active |
| Lapiplasty SpeedPlate | SK54 | FDA UDI | Class II | Active |
| Countersink | 1405-2549 | FDA UDI | Class I | Active |
| Seeker-Fulcrum | 1405-2477 | FDA UDI | Class I | Active |
| Countersink | 1405-2317 | FDA UDI | Class I | Active |
| Drill Bit | 1405-2021 | FDA UDI | Class I | Active |
| Lapidus Trial | 02-00312 | FDA UDI | Class I | Active |
| Drill Bit | 02-00018 | FDA UDI | Class I | Active |
| Cut Guide | 02-00143 | FDA UDI | Class I | Active |
| Lapiplasty System 1 | SK12 | FDA UDI | Class II | Active |
| Snap-Off Screw System | SK21 | FDA UDI | Class II | Active |
| Reamer | 1405-2463 | FDA UDI | Class I | Active |
| Instrument Tray | 02-00192 | FDA UDI | Class I | Active |
| Drill Bit | 1405-2158 | FDA UDI | Class I | Active |
| Scalpel | SN29 | FDA UDI | Class I | Active |
| K-Wire | 02-00159 | FDA UDI | Class I | Active |
| MIS Beveled Screw | SF4060 | FDA UDI | Class II | Active |
| Cut Guide | 1405-2546 | FDA UDI | Class I | Active |
| Olive Wire | 1405-2002 | FDA UDI | Class I | Active |
| Nanoplasty System | SD29 | FDA UDI | Class II | Active |
| Olive Wire | 1405-2001 | FDA UDI | Class I | Active |
| Reamer | 1405-2464 | FDA UDI | Class I | Active |
| Nanoplasty System | 02-00170 | FDA UDI | Class II | Active |
| Guide Sleeve | 02-00209 | FDA UDI | Class I | Active |
| MIS Beveled Screw | SF3024 | FDA UDI | Class II | Active |
| Planer | 1405-2545 | FDA UDI | Class I | Active |
| Screwdriver | 1405-2235 | FDA UDI | Class I | Active |
| Osteotome | 1405-2568 | FDA UDI | Class I | Active |
| Lapiplasty SpeedPlate | NK16 | FDA UDI | Class II | Active |
| Hammertoe Fixation System | SK32 | FDA UDI | Class II | Active |
| Cut Guide | 1405-2560 | FDA UDI | Class I | Active |
| MIS Beveled Screw | SF3044 | FDA UDI | Class II | 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. |