FDA 510(k)
FDA class 2
Substantially Equivalent for Some Indications
🇺🇸 United States
PROFORM HA HIP SYSTEM
K Number: K934162
·
Decision Mar 9, 1994
Classifications
1
FEI Numbers
61
Registration Numbers
61
Same Product Code
22
Applicant Total
40
Review Days
194
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Basic Information
- Device Name
- PROFORM HA HIP SYSTEM
- K Number
- K934162
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent for Some Indications
- Applicant
- Stelkast Company
- Date Received
- August 27, 1993
- Decision Date
- March 9, 1994
- Product Code
- JDO
- 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 |
|---|---|---|---|
| JDO | Device, Fixation, Proximal Femoral, Implant | FDA class 2 | Orthopedic |
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Other Clearances by Stelkast Company
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| K033944 | STELKAST 32MM MODULAR CERAMIC FEMORAL HEAD | Mar 12, 2004 | 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 |