FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
Fine TTO
K Number: K250394
·
Decision Oct 21, 2025
Classifications
1
FEI Numbers
37
Registration Numbers
37
Same Product Code
26
Applicant Total
16
Review Days
251
Basic Information
- Device Name
- Fine TTO
- K Number
- K250394
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bodycad Laboratories, Inc.
- Date Received
- February 12, 2025
- Decision Date
- October 21, 2025
- Product Code
- PBF
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| PBF | Orthopaedic Surgical Planning And Instrument Guides | FDA class 2 | Orthopedic |
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Other Clearances by Bodycad Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K253300 | Fine Osteotomy | Oct 28, 2025 | Substantially Equivalent |
| K250923 | Fine Osteotomy | Aug 21, 2025 | Substantially Equivalent |
| K241356 | Fine Osteotomy | Sep 5, 2024 | Substantially Equivalent |
| K240703 | Fine Osteotomy | Apr 12, 2024 | Substantially Equivalent |
| K240066 | Fine Osteotomy | Feb 9, 2024 | Substantially Equivalent |
| K231314 | Fine Osteotomy | Jun 2, 2023 | Substantially Equivalent |
| K212307 | BC Reflex Uni Knee System | Oct 12, 2021 | Substantially Equivalent |
| K211895 | BC Reflex Uni Knee System | Aug 20, 2021 | Substantially Equivalent |
| K211646 | FINE Osteotomy | Jul 28, 2021 | Substantially Equivalent |
| K203697 | BC Reflex Uni Knee System | Mar 12, 2021 | Substantially Equivalent |