FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SLT FEMORAL HEAD
K Number: K932222
·
Decision May 27, 1994
Classifications
1
FEI Numbers
276
Registration Numbers
276
Same Product Code
530
Applicant Total
74
Review Days
385
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Basic Information
- Device Name
- SLT FEMORAL HEAD
- K Number
- K932222
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3353
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Dow Corning Wright
- Date Received
- May 7, 1993
- Decision Date
- May 27, 1994
- 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 Dow Corning Wright
| K Number | Device Name | ||
|---|---|---|---|
| K932210 | ORTHOLOC ADVANTIM REVISION FEMORAL COMPONENT | Sep 7, 1994 | Substantially Equivalent for Some Indications |
| K932911 | ORTHOLOC ADVANTIM L.S. TIBIAL COMPONENT | Jun 30, 1994 | Substantially Equivalent for Some Indications |
| K934354 | LACEY ALL POLYETHYLENE TIBIAL COMPONENT | Jun 3, 1994 | Substantially Equivalent |
| K932858 | ORTHOLOC ADVANTIM TIBIAL BASE COMPONENT | Feb 16, 1994 | Substantially Equivalent |
| K930228 | ORTHOLOC ADVANTIM TIBIAL STEM 5 DEGREE | Nov 30, 1993 | Substantially Equivalent |
| K925900 | LACEY REVISION FEMORAL COMPONENT | Aug 24, 1993 | Substantially Equivalent |
| K930189 | ORTHOLOC(R) ADVANTIM(TM) POSTERIOR STAB FEMOR COMP | Aug 6, 1993 | Substantially Equivalent for Some Indications |
| K930188 | ORTHOLOC(R) ADVANTIM(TM) FEMORAL COMPONENT | Aug 3, 1993 | Substantially Equivalent |
| K930190 | ORTHOLOC(R) ADVANTIM(TM) NON-POR COAT FEMOR COMP | Aug 2, 1993 | Substantially Equivalent |
| K926257 | ORTHOLOC ADVANTIM THICK TIBIAL BASE COMPONENT | May 18, 1993 | Substantially Equivalent |