FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
CAS PSI KNEE SYSTEM
K Number: K131409
·
Decision Sep 13, 2013
Classifications
1
FEI Numbers
315
Registration Numbers
315
Same Product Code
910
Applicant Total
14
Review Days
121
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Basic Information
- Device Name
- CAS PSI KNEE SYSTEM
- K Number
- K131409
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3560
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Orthosoft, Inc.
- Date Received
- May 15, 2013
- Decision Date
- September 13, 2013
- 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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Other Clearances by Orthosoft, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K100599 | CAS FIXATION PIN 3.2 DIA X 180 MM STR, CAS FIXATON PIN 3.2 DIA X 80 MM STR, CAS FIXATON PIN 3.2 DIA X 150 MM | Apr 5, 2010 | Substantially Equivalent |
| K071929 | NAVITRACK SYSTEM- PARTIAL HIP RESURFACING UNIVERSAL | Sep 19, 2007 | Substantially Equivalent |
| K071714 | NAVITRACK SYSTEM - OS UNICONDYLAR KNEE UNIVERSAL, MODEL# PRO-06003 | Jul 20, 2007 | Substantially Equivalent |
| K060336 | NAVITRACK SYSTEM-OS KNEE UNIVERSAL, MODEL PRO-05002 | Apr 28, 2006 | Substantially Equivalent |
| K043536 | NAVITRACK SYSTEM - S&N IMAGE FREE KNEE | Jan 14, 2005 | Substantially Equivalent |
| K041369 | NAVITRACK SYSTEM - S&N IMAGE FREE HIP, MODEL PRO-03017 | Jun 22, 2004 | Substantially Equivalent |
| K032917 | NAVITRACK SYSTEM - TOTAL HIP REPLACEMENT CT-FREE | Oct 21, 2003 | Substantially Equivalent |
| K030827 | NAVITRACK SYSTEM: TOTAL HIP REPLACEMENT CT-FREE CUP, MODEL 900.204 | May 23, 2003 | Substantially Equivalent |
| K031156 | NAVITRACK SYSTEM-FLUOROSPINE, MODEL 900.005 | May 9, 2003 | Substantially Equivalent |
| K022364 | NAVITRACK SYSTEM TOTAL HIP REPLACEMENT,MODEL 900.200 | Feb 4, 2003 | Substantially Equivalent |