FDA Registration
Active
🇺🇸 United States
TREACE MEDICAL CONCEPTS, INC.
Reg #: 3011623994
·
FEI: 3011623994
·
Expires 2026
Products
25
Proprietary Names
1
Establishment Types
4
Classifications
25
Registration Details
- Registration Name
- TREACE MEDICAL CONCEPTS, INC.
- Registration Number
- 3011623994
- FEI Number
- 3011623994
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 100 Palmetto Park Place
- City
- PONTE VEDRA
- State
- FL
- ZIP
- 32081
- Country
- US
Regulatory Submissions
- 510(k) Number
- K143717
Owner / Operator
- Firm Name
- Treace Medical Concepts, Inc.
- Operator Number
- 10050008
- Address
- 100 Palmetto Park Place
- City
- Ponte Vedra
- State
- FL
- Postal Code
- 32081
- Country
- US
- Correspondent
- Kristi L Gandy
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2015-10-06 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2015-10-06 |
| Osteotome | HWM | Class 1 | General, Plastic Surgery | No | 2021-12-02 |
| Instrument, Compression | HWN | Class 1 | Orthopedic | No | 2022-06-03 |
| Broach | HTQ | Class 1 | Orthopedic | No | 2025-07-22 |
| Staple, Fixation, Bone | JDR | Class 2 | Orthopedic | No | 2024-10-21 |
| Tamp | HXG | Class 1 | Orthopedic | No | 2025-03-20 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | Class 1 | General, Plastic Surgery | No | 2016-07-25 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2016-12-08 |
| Tap, Bone | HWX | Class 1 | Orthopedic | No | 2023-08-18 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2022-06-03 |
| Gauge, Depth | HTJ | Class 1 | Orthopedic | No | 2021-09-20 |
| Countersink | HWW | Class 1 | Orthopedic | No | 2021-09-20 |
| Blade, Saw, General & Plastic Surgery, Surgical | GFA | Class 1 | General, Plastic Surgery | No | 2025-02-24 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2016-03-01 |
| Orthopaedic Surgical Planning And Instrument Guides | PBF | Class 2 | Orthopedic | No | 2023-08-09 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2015-10-06 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2018-08-23 |
| Scalpel, One-Piece | GDX | Class 1 | General, Plastic Surgery | No | 2021-12-02 |
| System, Digital Image Communications, Radiological | LMD | Class 1 | Radiology | No | 2026-04-24 |
| Bender | HXW | Class 1 | Orthopedic | No | 2022-06-03 |
| Chisel, Surgical, Manual | FZO | Class 1 | General, Plastic Surgery | No | 2022-08-24 |
| Template | HWT | Class 1 | Orthopedic | No | 2022-08-24 |
| Rasp | HTR | Class 1 | General, Plastic Surgery | No | 2025-05-20 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2022-08-24 |
Proprietary Names
Saw Blade
Establishment Types
Manufacture Medical Device
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility
Repack or Relabel Medical Device