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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 4 of 10| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Guide | 02-00308 | FDA UDI | Class I | Active |
| Rasp | 02-00335 | FDA UDI | Class I | Active |
| TMC PSI Cut Guide System | NK28 | FDA UDI | Class I | Active |
| Cut Guide | 1405-2261 | FDA UDI | Class I | Active |
| Cut Guide | 1405-2544 | FDA UDI | Class I | Active |
| Screwdriver | 02-00191 | FDA UDI | Class I | Active |
| TMC PSI Cut Guide System | NK14 | FDA UDI | Class I | Active |
| Drill Bit | 02-00175 | FDA UDI | Class I | Active |
| Drill Guide | 02-00061 | FDA UDI | Class I | Active |
| K-wire Sleeve | 02-00301 | FDA UDI | Class I | Active |
| Incision Guide | 02-00146 | FDA UDI | Class I | Active |
| Scalpel | 1405-2566 | FDA UDI | Class I | Active |
| Lapiplasty SpeedPlate | SK48 | FDA UDI | Class II | Active |
| Tail Tack | 02-00356 | FDA UDI | Class I | Active |
| Targeting Guide | 02-00291 | FDA UDI | Class I | Active |
| Cotton Trial | 02-00322 | FDA UDI | Class I | Active |
| MIS Beveled Screw | SF4062 | FDA UDI | Class II | Active |
| MTP Trial | 02-00319 | FDA UDI | Class I | Active |
| MIS Beveled Screw | SF4028 | FDA UDI | Class II | Active |
| Lapiplasty SpeedPlate | 02-00103 | FDA UDI | Class II | Active |
| Cut Guide | 1405-2351 | FDA UDI | Class I | Active |
| Instrument Tray | 02-00248 | FDA UDI | Class I | Active |
| Drill Bit | 1405-2433 | FDA UDI | Class I | Active |
| Instrument Tray | 1405-2259 | FDA UDI | Class I | Active |
| cut guide, fulcrum, seeker | 1405-2521 | FDA UDI | Class I | Active |
| Fulcrum | 1405-2143 | FDA UDI | Class I | Active |
| Elevator | 02-00207 | FDA UDI | Class I | Active |
| Lapiplasty SpeedPlate | SK52 | FDA UDI | Class II | Active |
| Scalpel | 02-00004 | FDA UDI | Class I | Active |
| Drill Sleeve | 1405-2310 | FDA UDI | Class I | Active |
| TMC PSI Cut Guide System | PSI-02-00230 | FDA UDI | Class II | Active |
| MIS Beveled Screw | SF4050 | FDA UDI | Class II | Active |
| Cut Guide | 1405-2333 | FDA UDI | Class I | Active |
| Targeter | 02-00279 | FDA UDI | Class I | Active |
| Nanoplasty System | 02-00152 | FDA UDI | Class II | Active |
| Drill Guide | 02-00359 | FDA UDI | Class I | Active |
| Alignment Guide | 01-1000-024 | FDA UDI | Class I | Active |
| Drill Guide | 02-00062 | FDA UDI | Class I | Active |
| Lapiplasty SpeedPlate | SK53 | FDA UDI | Class II | Active |
| Drill Bit | 02-00123 | FDA UDI | Class I | Active |
| Reamer | 1405-2025 | FDA UDI | Class I | Active |
| Seeker-Fulcrum | 1405-2419 | FDA UDI | Class I | Active |
| Fastpitch 2.7mm High Pitch Locking Screw | SD21 | FDA UDI | Class II | Active |
| Reamer | 1405-2398 | FDA UDI | Class I | Active |
| Cut Guide | 1405-2444 | FDA UDI | Class I | Active |
| Lapiplasty System 2 | SD16 | FDA UDI | Class II | Active |
| TMC PSI Cut Guide System | NK25 | FDA UDI | Class I | Active |
| Cut Guide | 02-00142 | FDA UDI | Class I | Active |
| Instrument Tray | 02-00425 | FDA UDI | Class I | Active |
| Elevator | 02-00346 | 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. |