FDA 510(k)
FDA class 2
Substantially Equivalent for Some Indications
🇺🇸 United States
HA TI-FIT ACETABULAR AND FEMORAL COMPONENT
K Number: K922621
·
Decision Mar 17, 1994
Classifications
1
FEI Numbers
191
Registration Numbers
191
Same Product Code
157
Applicant Total
87
Review Days
652
Basic Information
- Device Name
- HA TI-FIT ACETABULAR AND FEMORAL COMPONENT
- K Number
- K922621
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3353
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent for Some Indications
- Applicant
- SMITH & NEPHEW RICHARDS, INC.
- Date Received
- June 3, 1992
- Decision Date
- March 17, 1994
- 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 |
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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 |