FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
WEBER-STUHMER HIP PROSTHESIS STEM
K Number: K841391
·
Decision Apr 13, 1984
Classifications
1
FEI Numbers
227
Registration Numbers
227
Same Product Code
562
Applicant Total
16
Review Days
10
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Basic Information
- Device Name
- WEBER-STUHMER HIP PROSTHESIS STEM
- K Number
- K841391
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3350
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- Allo Pro Corp.
- Date Received
- April 3, 1984
- Decision Date
- April 13, 1984
- 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 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 |
| K871453 | ZWEYMUELLER-SL HIP PROSTHESIS STEM | Jul 13, 1987 | Substantially Equivalent |
| K851213 | ZWEYMULLER CUP | May 28, 1985 | Substantially Equivalent |
| K830948 | WEBER/STIIHMER FEMORAL HEAD PROSTHESIS | Jul 12, 1983 | Substantially Equivalent |