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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 2 of 10| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Reamer | 1405-2401 | FDA UDI | Class I | Active |
| MIS Beveled Screw | SF3032 | FDA UDI | Class II | Active |
| Compressor & Distractor | 1405-2427 | FDA UDI | Class I | Active |
| Scalpel | 1405-2553 | FDA UDI | Class I | Active |
| K-wire Sleeve | 02-00294 | FDA UDI | Class I | Active |
| Threaded Handle | 02-00323 | FDA UDI | Class I | Active |
| Pin | 02-00333 | FDA UDI | Class I | Active |
| Cut Guide | 02-00129 | FDA UDI | Class I | Active |
| Lapiplasty SpeedPlate | SK47 | FDA UDI | Class II | Active |
| Lapiplasty SpeedPlate | 02-00002 | FDA UDI | Class II | Active |
| Guide Sleeve | 02-00109 | FDA UDI | Class I | Active |
| Reamer | NN16 | FDA UDI | Class I | Active |
| Cut Guide | 1405-2572 | FDA UDI | Class I | Active |
| Compressor & Distractor | 1405-2551 | FDA UDI | Class I | Active |
| MIS Beveled Screw | SF3020 | FDA UDI | Class II | Active |
| K-Wire | 1405-2177 | FDA UDI | Class I | Active |
| Drill | 02-00229 | FDA UDI | Class I | Active |
| Pin Guide Handle | 01-1000-010 | FDA UDI | Class I | Active |
| Olive Wire | 1405-2376 | FDA UDI | Class I | Active |
| K-wire Sleeve | 02-00369 | FDA UDI | Class I | Active |
| Reamer | NN18 | FDA UDI | Class I | Active |
| K-Wire | 02-00206 | FDA UDI | Class I | Active |
| MIS Beveled Screw | SF4036 | FDA UDI | Class II | Active |
| Lapiplasty | SK19 | FDA UDI | Class II | Active |
| Drill Tack | 02-00149 | FDA UDI | Class I | Active |
| Derotation Handle | 01-1000-008 | FDA UDI | Class I | Active |
| Seeker-Fulcrum | 1405-2481 | FDA UDI | Class I | Active |
| Lapiplasty Lesser TMT Fixation Pack | SK28 | FDA UDI | Class II | Active |
| Reamer | NN17 | FDA UDI | Class I | Active |
| Lapiplasty SpeedPlate | 02-00178 | FDA UDI | Class II | Active |
| Pin | 01-1000-001 | FDA UDI | Class I | Active |
| Positioner | 1405-2196 | FDA UDI | Class I | Active |
| Cut Guide | 1405-2362 | FDA UDI | Class I | Active |
| Compressor & Distractor | 1405-2305 | FDA UDI | Class I | Active |
| Lapidus Trial | 02-00311 | FDA UDI | Class I | Active |
| MIS Beveled Screw | SF4030 | FDA UDI | Class II | Active |
| Instrument Tray | 1405-2231 | FDA UDI | Class I | Active |
| Planer | 1405-2511 | FDA UDI | Class I | Active |
| MIS Beveled Screw | SF4040 | FDA UDI | Class II | Active |
| Drill Bit | 1405-2431 | FDA UDI | Class I | Active |
| Seeker-Fulcrum | 1405-2457 | FDA UDI | Class I | Active |
| Nanoplasty System | 02-00202 | FDA UDI | Class II | Active |
| Positioner | 1405-2383-04 | FDA UDI | Class I | Active |
| Seeker-Fulcrum | 1405-2418 | FDA UDI | Class I | Active |
| MIS Beveled Screw | SF3038 | FDA UDI | Class II | Active |
| Plate Tack | 1405-2248 | FDA UDI | Class I | Active |
| Scalpel | 1405-2606 | FDA UDI | Class I | Active |
| Evans Trial | 02-00316 | FDA UDI | Class I | Active |
| Drill Guide | 02-00111 | FDA UDI | Class I | Active |
| Nanoplasty System | 02-00153 | 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. |