FDA 510(k)
FDA class 3
Substantially Equivalent
🇺🇸 United States
FMP METAL/METAL ACETABULAR INSERT
K Number: K003250
·
Decision Jan 25, 2001
Classifications
1
FEI Numbers
53
Registration Numbers
53
Same Product Code
113
Applicant Total
85
Review Days
100
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Basic Information
- Device Name
- FMP METAL/METAL ACETABULAR INSERT
- K Number
- K003250
- Device Class
- FDA class 3
- Clearance Type
- Traditional
- Regulation Number
- 888.3330
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Encore Orthopedics, Inc.
- Date Received
- October 17, 2000
- Decision Date
- January 25, 2001
- 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.
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Other Clearances by Encore Orthopedics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K032905 | 3DKNEE POROUS COATED FEMORAL COMPONENT | Jul 6, 2004 | Substantially Equivalent |
| K020114 | 3D KNEE | Jul 12, 2002 | Substantially Equivalent |
| K020741 | UNICONDYLAR KNEE | Jun 4, 2002 | Substantially Equivalent |
| K020236 | MODIFICATION TO PASS SPINAL SYSTEM | Feb 14, 2002 | Substantially Equivalent |
| K020170 | KEYSTONE HIP SYSTEM CALCAR REPLACEMENT BODY AND BUILD UP | Feb 11, 2002 | Substantially Equivalent |
| K013490 | CEMENTED CALCAR HIP SYSTEM | Jan 17, 2002 | Substantially Equivalent |
| K013442 | PASS SPINAL SYSTEM | Jan 15, 2002 | Substantially Equivalent |
| K003324 | PLASMA SPRAYED SHOULDER | Dec 6, 2001 | Substantially Equivalent |
| K013431 | PASS SPINAL SYSTEM | Nov 15, 2001 | Substantially Equivalent |
| K013191 | PASS SPINAL SYSTEM | Oct 24, 2001 | Substantially Equivalent |