FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Optimotion Implants Porous Metal-Backed Patella
K Number: K220049
·
Decision Mar 14, 2022
Classifications
1
FEI Numbers
219
Registration Numbers
219
Same Product Code
142
Applicant Total
3
Review Days
67
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Basic Information
- Device Name
- Optimotion Implants Porous Metal-Backed Patella
- K Number
- K220049
- 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
- January 6, 2022
- Decision Date
- March 14, 2022
- 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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