FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SWANSON TITANIUM CONDYLAR IMPLANT
K Number: K864488
·
Decision Apr 15, 1987
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
25
Applicant Total
74
Review Days
153
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Basic Information
- Device Name
- SWANSON TITANIUM CONDYLAR IMPLANT
- K Number
- K864488
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3770
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- Dow Corning Wright
- Date Received
- November 13, 1986
- Decision Date
- April 15, 1987
- Product Code
- KYI
- 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 |
|---|---|---|---|
| KYI | Prosthesis, Wrist, Carpal Trapezium | FDA class 2 | Orthopedic |
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| 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 |