FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
The Progressive Orthopaedic Total Hip System
K Number: K151424
·
Decision Jul 27, 2016
Classifications
1
FEI Numbers
266
Registration Numbers
266
Same Product Code
560
Applicant Total
5
Review Days
426
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Basic Information
- Device Name
- The Progressive Orthopaedic Total Hip System
- K Number
- K151424
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3358
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- The Progressive Orthopaedic Company, LLC
- Date Received
- May 28, 2015
- Decision Date
- July 27, 2016
- Product Code
- LPH
- 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 |
|---|---|---|---|
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | FDA class 2 | Orthopedic |
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Other Clearances by The Progressive Orthopaedic Company, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K183344 | The Progressive Orthopaedic Company Total Knee System II | Mar 18, 2019 | 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 |