FDA 510(k)
FDA class 3
Substantially Equivalent
🇺🇸 United States
ZWEYMUELLER-SL HIP PROSTHESIS STEM
K Number: K871453
·
Decision Jul 13, 1987
Classifications
1
FEI Numbers
53
Registration Numbers
53
Same Product Code
113
Applicant Total
16
Review Days
91
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Basic Information
- Device Name
- ZWEYMUELLER-SL HIP PROSTHESIS STEM
- K Number
- K871453
- Device Class
- FDA class 3
- Clearance Type
- Traditional
- Regulation Number
- 888.3330
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- Allo Pro Corp.
- Date Received
- April 13, 1987
- Decision Date
- July 13, 1987
- 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
FDA 510(k)
FDA Class 3
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DYNASTY BIOFOAM SHELL
FDA 510(k)
FDA Class 3
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METAL-ON-METAL HIP SYSTEMS-ADDITIONAL CONTRAINDICATIONS
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FDA Class 3
·Orthopedic
CONSERVE THIN SHELL
FDA 510(k)
FDA Class 3
·Orthopedic
PRESERVE HIP STEM
FDA 510(k)
FDA Class 3
·Orthopedic
PROFEMUR GLADIATOR HA HIP STEM
FDA 510(k)
FDA Class 3
·Orthopedic
Other Clearances by Allo Pro Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K901581 | GSB ELBOW | Oct 22, 1990 | Substantially Equivalent |
| K900425 | SURGICAL COTTON GLOVES | Sep 7, 1990 | Substantially Equivalent |
| K900392 | CENTERING PLUG | Mar 1, 1990 | Substantially Equivalent |
| K896669 | WEBER PERMALOCK | Feb 6, 1990 | Substantially Equivalent for Some Indications |
| K892644 | BIOLOX CERAMIC BALL | Oct 19, 1989 | Substantially Equivalent |
| K885049 | RS-CUP ACETABULAR PROSTHESIS | Jan 13, 1989 | Substantially Equivalent |
| K864999 | KENNEDY STEM | Sep 9, 1987 | Substantially Equivalent |
| K851213 | ZWEYMULLER CUP | May 28, 1985 | Substantially Equivalent |
| K841391 | WEBER-STUHMER HIP PROSTHESIS STEM | Apr 13, 1984 | Substantially Equivalent |
| K830948 | WEBER/STIIHMER FEMORAL HEAD PROSTHESIS | Jul 12, 1983 | Substantially Equivalent |