FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Patello-Femoral Wave (Kahuna) Arthroplasty System
K Number: K181280
·
Decision Jun 14, 2018
Classifications
1
FEI Numbers
117
Registration Numbers
117
Same Product Code
26
Applicant Total
26
Review Days
30
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Basic Information
- Device Name
- Patello-Femoral Wave (Kahuna) Arthroplasty System
- K Number
- K181280
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3540
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Arthrosurface, Inc.
- Date Received
- May 15, 2018
- Decision Date
- June 14, 2018
- Product Code
- KRR
- 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 |
|---|---|---|---|
| KRR | Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer | FDA class 2 | Orthopedic |
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