FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CPS, CEMENTED CUP SYSTEM
K Number: K962086
·
Decision Aug 7, 1996
Classifications
1
FEI Numbers
227
Registration Numbers
227
Same Product Code
562
Applicant Total
4
Review Days
70
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
- CPS, CEMENTED CUP SYSTEM
- K Number
- K962086
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3350
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Artos Medical Products GmbH
- Date Received
- May 29, 1996
- Decision Date
- August 7, 1996
- Product Code
- JDI
- 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 |
|---|---|---|---|
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JDI), ordered by most recent decision date.
Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral Head
FDA 510(k)
FDA Class 2
·Orthopedic
Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained Liners
FDA 510(k)
FDA Class 2
·Orthopedic
Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip Stems
FDA 510(k)
FDA Class 2
·Orthopedic
Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee Component
FDA 510(k)
FDA Class 2
·Orthopedic
Stryker Orthopaedics Hip Systems Labeling Update
FDA 510(k)
FDA Class 2
·Orthopedic
Global Modular Replacement System
FDA 510(k)
FDA Class 2
·Orthopedic