FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODIFICAITON TO: CARDO MEDICAL HIP SYSTEM
K Number: K094045
·
Decision Apr 22, 2010
Classifications
1
FEI Numbers
266
Registration Numbers
266
Same Product Code
560
Applicant Total
3
Review Days
112
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
- MODIFICAITON TO: CARDO MEDICAL HIP SYSTEM
- K Number
- K094045
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3358
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cardo Medical Corp.
- Date Received
- December 31, 2009
- Decision Date
- April 22, 2010
- 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