FDA 510(k)
FDA class 2
Substantially Equivalent for Some Indications
🇺🇸 United States
ESOP S/C FEMORAL STEM
K Number: K964878
·
Decision Mar 5, 1998
Classifications
1
FEI Numbers
189
Registration Numbers
189
Same Product Code
158
Applicant Total
4
Review Days
455
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
- ESOP S/C FEMORAL STEM
- K Number
- K964878
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3353
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent for Some Indications
- Applicant
- Fournitures Hospitalieres
- Date Received
- December 5, 1996
- Decision Date
- March 5, 1998
- Product Code
- MEH
- 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 |
|---|---|---|---|
| MEH | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MEH), ordered by most recent decision date.
Allure Hip Stem and Intramedullary Plugs
FDA 510(k)
FDA Class 2
·Orthopedic
Mfinity Femoral System
FDA 510(k)
FDA Class 2
·Orthopedic
Trivicta® Hip Stem
FDA 510(k)
FDA Class 2
·Orthopedic
Resolve Modular Revision Hip Stem
FDA 510(k)
FDA Class 2
·Orthopedic
Alteon® HA Femoral Stems
FDA 510(k)
FDA Class 2
·Orthopedic
World Liner
FDA 510(k)
FDA Class 2
·Orthopedic