FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
The Progressive Orthopaedic Company Total Knee System II
K Number: K183344
·
Decision Mar 18, 2019
Classifications
1
FEI Numbers
315
Registration Numbers
315
Same Product Code
910
Applicant Total
5
Review Days
105
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Basic Information
- Device Name
- The Progressive Orthopaedic Company Total Knee System II
- K Number
- K183344
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3560
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- The Progressive Orthopaedic Company, LLC
- Date Received
- December 3, 2018
- Decision Date
- March 18, 2019
- 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 The Progressive Orthopaedic Company, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K151424 | The Progressive Orthopaedic Total Hip System | Jul 27, 2016 | Substantially Equivalent |
| K150783 | Progressive Orthopaedic Total Knee System | Jun 23, 2015 | Substantially Equivalent |
| K142649 | Progressive Orthopedic Total Knee System | Mar 24, 2015 | Substantially Equivalent |
| K143314 | Progressive Orthopaedic Total Hip System | Feb 27, 2015 | Substantially Equivalent |