FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODULAR ACETABULAR CUP SYSTEM
K Number: K920430
·
Decision Jul 21, 1992
Classifications
1
FEI Numbers
231
Registration Numbers
231
Same Product Code
560
Applicant Total
87
Review Days
169
Basic Information
- Device Name
- MODULAR ACETABULAR CUP SYSTEM
- K Number
- K920430
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3350
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- SMITH & NEPHEW RICHARDS, INC.
- Date Received
- February 3, 1992
- Decision Date
- July 21, 1992
- 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 |
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Other Clearances by SMITH & NEPHEW RICHARDS, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K965224 | EMPOWER ANTERIOR DIRECT SCREWS | May 8, 1997 | Substantially Equivalent |
| K963509 | GLOBAL TAPER TAPERED HIP SYSTEM, GT SPECTRON | Jan 27, 1997 | Substantially Equivalent |
| K960444 | FINN ROD TO ROD CONNECTOR | Jan 24, 1997 | Substantially Equivalent |
| K964163 | TRIMAX NAIL SYSTEM | Dec 27, 1996 | Substantially Equivalent |
| K962557 | GENESIS II ZIRCONIUM FEMORAL COMPONENT/PROFIX ZIRCONIUM FEMORAL COMPONENT | Dec 5, 1996 | Substantially Equivalent for Some Indications |
| K963486 | REVISION HIP SYSTEM | Nov 27, 1996 | Substantially Equivalent |
| K962541 | REFLECTION ACETABULAR REINFORCEMENT RINGS | Sep 17, 1996 | Substantially Equivalent |
| K962808 | ILIZAROV EXTERNAL FIXATION SYSTEM | Aug 19, 1996 | Substantially Equivalent |
| K962137 | GENESIS II CONSTRAINED SYSTEM | Aug 2, 1996 | Substantially Equivalent |
| K955767 | COFIED MODULAR SHOULDER SYSTEM | Apr 8, 1996 | Substantially Equivalent for Some Indications |