Fine TTO™
FDA 510(k) clearance K250394 · decided 2025-10-21
Clearance details
- K-number
- K250394
- Device name
- Fine TTO™
- Applicant
- Bodycad Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2025-02-12
- Decision date
- 2025-10-21
- Days to decision
- 251 days
- Clearance type
- Traditional
- Product code
- PBF
- Device class
- 2
- Regulation number
- 888.3030
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Quebec, CA
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| MedCAD® AccuStride™ System (K252064) | Medcad | 2026-03-27 |
| VSP Orthopedics System (K250711) | 3D Systems, Inc. | 2025-12-05 |
| MyPAO SA guides (K242603) | Medacta International S.A. | 2025-11-19 |
| MedCAD® AccuStride™ System (K251709) | Medcad | 2025-11-04 |
| Newclip Patient-matched instrumentation non sterile PSI (K250767) | Newclip Technics | 2025-10-01 |
| CORIOGRAPH Pre-Op Planning and Modeling Services (K250921) | Blue Belt Technologies, Inc. | 2025-06-25 |
| MedCAD® AccuStride™ System (K241811) | Medcad | 2025-03-13 |
| Newclip Patient-matched instrumentation non sterile PSI (K243912) | Newclip Technics | 2025-02-13 |
| Newclip Patient-matched instrumentation non sterile PSI (K240415) | Newclip Technics | 2024-11-07 |
| CORIOGRAPH Knee Pre-Op Plan (K240113) | Smith & Nephew, Inc. | 2024-03-18 |
| Fine Osteotomy™ (K240066) | Bodycad Laboratories, Inc. | 2024-02-09 |
| Newclip Patient-matched instrumentation non sterile PSI (K221615) | Newclip Technics | 2023-10-25 |
Recalls involving this device
No recalls on record reference this clearance.