FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GEM INSET PATELLAR COMPONENT
K Number: K032950
·
Decision Dec 19, 2003
Classifications
1
FEI Numbers
315
Registration Numbers
315
Same Product Code
910
Applicant Total
33
Review Days
88
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Basic Information
- Device Name
- GEM INSET PATELLAR COMPONENT
- K Number
- K032950
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3560
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Kinamed, Inc.
- Date Received
- September 22, 2003
- Decision Date
- December 19, 2003
- 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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| K050897 | NAVIPRO SHOULDER SOFTWARE MODULE | May 24, 2005 | Substantially Equivalent |
| K033668 | NAVIPRO KNEE SOFTWARE MODULE | Mar 11, 2004 | Substantially Equivalent |
| K030256 | ISO-ELASTIC CERCLAGE SYSTEM | Oct 21, 2003 | Substantially Equivalent |
| K020764 | NAVIPRO | Jun 3, 2002 | Substantially Equivalent |
| K013982 | KINEMATCH PATELLO-FEMORAL RESURFACING IMPALANT | May 21, 2002 | Substantially Equivalent |
| K010101 | GEM POSTERIOR STABILIZED TOTAL KNEE SYSTEM | May 17, 2001 | Substantially Equivalent |
| K003347 | ORTHOPILOT | Feb 23, 2001 | Substantially Equivalent |
| K994214 | GEM KNEE SYSTEM | Jul 19, 2000 | Substantially Equivalent |