FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PIPELINE TOTAL HIP SYSTEM (LINE EXTENSION)
K Number: K130353
·
Decision Jul 1, 2013
Classifications
1
FEI Numbers
266
Registration Numbers
266
Same Product Code
560
Applicant Total
9
Review Days
139
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- PIPELINE TOTAL HIP SYSTEM (LINE EXTENSION)
- K Number
- K130353
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3358
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Pipeline Orthopedics
- Date Received
- February 12, 2013
- Decision Date
- July 1, 2013
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LPH), ordered by most recent decision date.
iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi Coating
FDA 510(k)
FDA Class 2
·Orthopedic
Taperloc® Complete Hip Stem
FDA 510(k)
FDA Class 2
·Orthopedic
G7® Revision Acetabular System
FDA 510(k)
FDA Class 2
·Orthopedic
Mpact 3D Metal Implants Extension DMLS Technology
FDA 510(k)
FDA Class 2
·Orthopedic
Velora Acetabular System
FDA 510(k)
FDA Class 2
·Orthopedic
TaperSet Hip System
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by Pipeline Orthopedics
| K Number | Device Name | ||
|---|---|---|---|
| K131368 | NEO KNEE SYSTEM | Oct 3, 2013 | Substantially Equivalent |
| K132046 | PIPELINE KNEE SYSTEM | Sep 23, 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 |