Treace Medical Systems (TMC) Plating System
FDA 510(k) clearance K240173 · decided 2024-02-22
Clearance details
- K-number
- K240173
- Device name
- Treace Medical Systems (TMC) Plating System
- Applicant
- Treace Medical Concepts, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2024-01-23
- Decision date
- 2024-02-22
- Days to decision
- 30 days
- Clearance type
- Special
- Product code
- HRS
- Device class
- 2
- Regulation number
- 888.3030
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Ponte Vedra, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Nanoplasty 3D Bunion Correction System Implant, Model Number: SK57. System contains the 01 recall (Z-2718-2024) | Treace Medical Concepts, Inc. | 2024-08-23 |