FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
STELKAST 32MM MODULAR CERAMIC FEMORAL HEAD
K Number: K033944
·
Decision Mar 12, 2004
Classifications
1
FEI Numbers
276
Registration Numbers
276
Same Product Code
530
Applicant Total
40
Review Days
84
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Basic Information
- Device Name
- STELKAST 32MM MODULAR CERAMIC FEMORAL HEAD
- K Number
- K033944
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3353
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Stelkast Company
- Date Received
- December 19, 2003
- Decision Date
- March 12, 2004
- Product Code
- LZO
- 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 |
|---|---|---|---|
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | FDA class 2 | Orthopedic |
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Other Clearances by Stelkast Company
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|---|---|---|---|
| K122883 | EXP TIBIAL INSERTS AND PATELLAR COMPONENTS FOR THE PROVEN GEN-FLEX TOTAL KNEE SYSTEM | Aug 5, 2013 | Substantially Equivalent |
| K122773 | CROSS-OVER ACETABULAR SHELL & LINER | Oct 9, 2012 | Substantially Equivalent |
| K094035 | EXP ACETABULAR LINER, MODELS SC3342 NON-HOODED 28MM, SC3343 HOODED 28MM | Mar 24, 2011 | Substantially Equivalent |
| K081458 | PROVEN STEM EXTENDER | Jun 6, 2008 | Substantially Equivalent |
| K063211 | PROVEN KNEE SYSTEM HIGH FLEXION TIBIAL INSERT | Jan 18, 2007 | Substantially Equivalent |
| K051976 | PROVEN REVISION MODULAR TIBIAL TRAY | Oct 17, 2005 | Substantially Equivalent |
| K032824 | STELKAST UNICONDYLAR KNEE SYSTEM | Nov 13, 2003 | Substantially Equivalent |
| K031901 | PROVEN REVISION FEMORAL AND PROVEN REVISION TIBIAL INSERT | Oct 10, 2003 | Substantially Equivalent |
| K032110 | PROCLASS PRESS FIT HIP STEM | Sep 22, 2003 | Substantially Equivalent |
| K030577 | PROVEN MODULAR TIBIAL TRAY | Mar 25, 2003 | Substantially Equivalent |