FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FREEDOM(R) STEMMED TIBIAL COMPONENTS
K Number: K111785
·
Decision Jun 29, 2012
Classifications
1
FEI Numbers
320
Registration Numbers
320
Same Product Code
902
Applicant Total
6
Review Days
371
Basic Information
- Device Name
- FREEDOM(R) STEMMED TIBIAL COMPONENTS
- K Number
- K111785
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3560
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- MAXX ORTHOPEDICS, INC.
- Date Received
- June 24, 2011
- Decision Date
- June 29, 2012
- 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 MAXX ORTHOPEDICS, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K150680 | Freedom Cementless Femoral Component | Jun 26, 2015 | Substantially Equivalent |
| K131481 | FREEDOM PCK COMPONENTS | Feb 21, 2014 | Substantially Equivalent |
| K091280 | FREEDOM TOTAL KNEE CRUCIATE RETAINING (CR) FEMORAL COMPONENT | Sep 25, 2009 | Substantially Equivalent |
| K090411 | FREEDOM METAL BACKED TIBIAL COMPONENT | Apr 7, 2009 | Substantially Equivalent |
| K082019 | FREEDOM TOTAL KNEE SYSTEM | Feb 6, 2009 | Substantially Equivalent |