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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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- —
- —
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- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 3011623994
- DUNS Number
- —
Catalogue (493)
Page 8 of 10| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Reamer | 1405-2461 | FDA UDI | Class I | Active |
| Reamer | NN13 | FDA UDI | Class I | Active |
| Broach | 02-00179 | FDA UDI | Class I | Active |
| Cross Joint Pin Guide, Right | 01-1000-025 | FDA UDI | Class I | Active |
| Nanoplasty System | 02-00198 | FDA UDI | Class II | Active |
| Cut Guide | 02-00139 | FDA UDI | Class I | Active |
| Seeker-Fulcrum | 1405-2482 | FDA UDI | Class I | Active |
| Lapiplasty® 4.0mm Fully Threaded Screw | SK37 | FDA UDI | Class II | Active |
| Pin Guide, Left | 01-1000-011 | FDA UDI | Class I | Active |
| K-Wire | 1405-2604 | FDA UDI | Class I | Active |
| Olive Wire | 1405-2015 | FDA UDI | Class I | Active |
| Cut Guide | 1405-2565 | FDA UDI | Class I | Active |
| SpeedPlate - SpeedAkin | 02-00254 | FDA UDI | Class II | Active |
| Cut Guide | 02-00141 | FDA UDI | Class I | Active |
| K-Wire | 1405-2592 | FDA UDI | Class I | Active |
| Drill Guide | 02-00226 | FDA UDI | Class I | Active |
| Seeker-Fulcrum | 1405-2420 | FDA UDI | Class I | Active |
| Reamer | 1405-2402 | FDA UDI | Class I | Active |
| TMC PSI Cut Guide System | PSI-01-2129-021 | FDA UDI | Class II | Active |
| Lapiplasty® 4.0mm Fully Threaded Screw | SK38 | FDA UDI | Class II | Active |
| TMC PSI Cut Guide System | PSI-01-2229-021 | FDA UDI | Class II | Active |
| Seeker-Fulcrum | 1405-2475 | FDA UDI | Class I | Active |
| Instrument Tray | 02-00250 | FDA UDI | Class I | Active |
| Cut Guide | 1405-2561 | FDA UDI | Class I | Active |
| Pin | 02-00409 | FDA UDI | Class I | Active |
| Lapiplasty System S4A | SK39 | FDA UDI | Class II | Active |
| MIS Beveled Screw | SF3026 | FDA UDI | Class II | Active |
| K-Wire | 02-00343 | FDA UDI | Class I | Active |
| Cut Guide | 1405-2518 | FDA UDI | Class I | Active |
| Plate Holder | 1405-2380 | FDA UDI | Class I | Active |
| Cut Guide | 1405-2564 | FDA UDI | Class I | Active |
| TMC PSI Cut Guide System | PSI-01-2329-021 | FDA UDI | Class II | Active |
| Drill Tack | 02-00445 | FDA UDI | Class I | Active |
| Plate Tack | 1405-2579 | FDA UDI | Class I | Active |
| TMC PSI Cut Guide System | PSI-02-1610-006 | FDA UDI | Class II | Active |
| Drill Guide Removal Instrument | 1405-2547 | FDA UDI | Class I | Active |
| Drill | 02-00228 | FDA UDI | Class I | Active |
| Lapiplasty SpeedPlate | 02-00003 | FDA UDI | Class II | Active |
| K-Wire | 02-00299 | FDA UDI | Class I | Active |
| Drill Sleeve | 1405-2164 | FDA UDI | Class I | Active |
| Guide Sleeve | 02-00100 | FDA UDI | Class I | Active |
| Drill Tack | 02-00119 | FDA UDI | Class I | Active |
| Screwdriver | 02-00187 | FDA UDI | Class I | Unknown |
| Pin Guide, Left | 01-1000-017 | FDA UDI | Class I | Active |
| Hammertoe Fixation System | SK33 | FDA UDI | Class II | Active |
| Seeker-Fulcrum | 1405-2478 | FDA UDI | Class I | Active |
| K-Wire | SN33 | FDA UDI | Class I | Active |
| Scalpel | 1405-2554 | FDA UDI | Class I | Active |
| Pin | 02-00431 | FDA UDI | Class I | Active |
| Reamer | 1405-2026 | FDA UDI | Class I | Active |
Related Companies
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Importers
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Authorities
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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. |