FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PIPELINE KNEE SYSTEM
K Number: K132046
·
Decision Sep 23, 2013
Classifications
1
FEI Numbers
315
Registration Numbers
315
Same Product Code
910
Applicant Total
9
Review Days
83
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Basic Information
- Device Name
- PIPELINE KNEE SYSTEM
- K Number
- K132046
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3560
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Pipeline Orthopedics
- Date Received
- July 2, 2013
- Decision Date
- September 23, 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 Pipeline Orthopedics
| K Number | Device Name | ||
|---|---|---|---|
| K131368 | NEO KNEE SYSTEM | Oct 3, 2013 | Substantially Equivalent |
| K130353 | PIPELINE TOTAL HIP SYSTEM (LINE EXTENSION) | Jul 1, 2013 | Substantially Equivalent |
| K131237 | PIPELINE TOTAL HIP SYSTEM | Jun 13, 2013 | Substantially Equivalent |
| K123692 | PIPELINE KNEE SYSTEM | May 24, 2013 | Substantially Equivalent |
| K122500 | NEO PS KNEE SYSTEM | May 3, 2013 | Substantially Equivalent |
| K120313 | NEO CR KNEE SYSTEM | Apr 20, 2012 | Substantially Equivalent |
| K113122 | PIPELINE CR PRIMARY KNEE SYSTEM | Mar 20, 2012 | Substantially Equivalent |
| K112802 | PIPELINE TOTAL HIP SYSTEM | Mar 9, 2012 | Substantially Equivalent |