FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
BC Reflex Uni Knee System
K Number: K191996
·
Decision Dec 5, 2019
Classifications
1
FEI Numbers
159
Registration Numbers
159
Same Product Code
113
Applicant Total
16
Review Days
132
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Basic Information
- Device Name
- BC Reflex Uni Knee System
- K Number
- K191996
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3520
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bodycad Laboratories, Inc.
- Date Received
- July 26, 2019
- Decision Date
- December 5, 2019
- Product Code
- HSX
- 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 |
|---|---|---|---|
| HSX | Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | FDA class 2 | Orthopedic |
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Other Clearances by Bodycad Laboratories, Inc.
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|---|---|---|---|
| K253300 | Fine Osteotomy | Oct 28, 2025 | Substantially Equivalent |
| K250394 | Fine TTO | Oct 21, 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 |