FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PLUS TOTAL KNEE SYSTEM, POLY PATELLAR BUTTON
K Number: K872134
·
Decision Oct 14, 1987
Classifications
1
FEI Numbers
320
Registration Numbers
320
Same Product Code
902
Applicant Total
60
Review Days
133
Basic Information
- Device Name
- PLUS TOTAL KNEE SYSTEM, POLY PATELLAR BUTTON
- K Number
- K872134
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3560
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- ORTHOMET, INC.
- Date Received
- June 3, 1987
- Decision Date
- October 14, 1987
- 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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|---|---|---|---|
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| K943873 | ORTHOMET ANATOMICALLY GUIDED CARPAL TUNNEL RELEASE SY | Apr 26, 1995 | Substantially Equivalent |
| K944752 | ORTHOMET RESURFACING FEMORAL COMPONENT | Dec 28, 1994 | Substantially Equivalent |
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| K931333 | ORTHOMET ACETABULAR CUP SYSTEM | Oct 14, 1994 | Substantially Equivalent |
| K932677 | AXIOM TOTAL KNEE SYSTEM | Oct 14, 1994 | Substantially Equivalent |
| K931678 | ORTHOMET LHMC FEMORAL STEM | Oct 14, 1994 | Substantially Equivalent |
| K923243 | PERFECTA TOTAL HIP SYSTEM | Jan 7, 1994 | Substantially Equivalent |