FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
KASM KNEE ARTICULATING SPACER MOLDS
K Number: K133449
·
Decision Feb 18, 2014
Classifications
1
FEI Numbers
315
Registration Numbers
315
Same Product Code
910
Applicant Total
45
Review Days
98
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Basic Information
- Device Name
- KASM KNEE ARTICULATING SPACER MOLDS
- K Number
- K133449
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3560
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ortho Development Corp.
- Date Received
- November 12, 2013
- Decision Date
- February 18, 2014
- Product Code
- JWH
- 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 |
|---|---|---|---|
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | FDA class 2 | Orthopedic |
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| K131022 | OVATION 10/12 HIP STEM | Oct 16, 2013 | Substantially Equivalent |
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