FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODIFIED WHITESIDE POSTERIOR STABILIZED TOTAL KNEE
K Number: K862136
·
Decision Jul 14, 1986
Classifications
1
FEI Numbers
159
Registration Numbers
159
Same Product Code
113
Applicant Total
74
Review Days
40
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Basic Information
- Device Name
- MODIFIED WHITESIDE POSTERIOR STABILIZED TOTAL KNEE
- K Number
- K862136
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3520
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- Dow Corning Wright
- Date Received
- June 4, 1986
- Decision Date
- July 14, 1986
- Product Code
- HSX
- 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 |
|---|---|---|---|
| HSX | Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | FDA class 2 | Orthopedic |
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Other Clearances by Dow Corning Wright
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|---|---|---|---|
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| K934354 | LACEY ALL POLYETHYLENE TIBIAL COMPONENT | Jun 3, 1994 | Substantially Equivalent |
| K932222 | SLT FEMORAL HEAD | May 27, 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 |