FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
The Optimotion Blue Plus Knee System
K Number: K240938
·
Decision Jun 27, 2024
Classifications
1
FEI Numbers
219
Registration Numbers
219
Same Product Code
142
Applicant Total
3
Review Days
83
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Basic Information
- Device Name
- The Optimotion Blue Plus Knee System
- K Number
- K240938
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3565
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Optimotion Implants, LLC
- Date Received
- April 5, 2024
- Decision Date
- June 27, 2024
- Product Code
- MBH
- 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 |
|---|---|---|---|
| MBH | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | FDA class 2 | Orthopedic |
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