FDA 510(k)
FDA class 3
Substantially Equivalent
🇺🇸 United States
HOWMEDICA THREADED ACETABULAR COMPONENT
K Number: K850840
·
Decision Jul 15, 1985
Classifications
1
FEI Numbers
53
Registration Numbers
53
Same Product Code
113
Applicant Total
30
Review Days
136
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Basic Information
- Device Name
- HOWMEDICA THREADED ACETABULAR COMPONENT
- K Number
- K850840
- Device Class
- FDA class 3
- Clearance Type
- Traditional
- Regulation Number
- 888.3330
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- Pfizer, Inc.
- Date Received
- March 1, 1985
- Decision Date
- July 15, 1985
- Product Code
- KWA
- 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 |
|---|---|---|---|
| KWA | Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) | FDA class 3 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KWA), ordered by most recent decision date.
PROFEMUR Z REVISION HIP STEM
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DYNASTY BIOFOAM SHELL
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CONSERVE THIN SHELL
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PRESERVE HIP STEM
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PROFEMUR GLADIATOR HA HIP STEM
FDA 510(k)
FDA Class 3
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