FDA 510(k)
FDA class 3
Substantially Equivalent for Some Indications
🇺🇸 United States
POROUS COATED TOTAL HIP PROS. ACETABULAR COMPONENT
K Number: K895607
·
Decision Nov 17, 1989
Classifications
1
FEI Numbers
50
Registration Numbers
50
Same Product Code
44
Applicant Total
186
Review Days
60
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Basic Information
- Device Name
- POROUS COATED TOTAL HIP PROS. ACETABULAR COMPONENT
- K Number
- K895607
- Device Class
- FDA class 3
- Clearance Type
- Traditional
- Regulation Number
- 888.3320
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent for Some Indications
- Applicant
- Exactech, Inc.
- Date Received
- September 18, 1989
- Decision Date
- November 17, 1989
- Product Code
- JDL
- 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 |
|---|---|---|---|
| JDL | Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component) | FDA class 3 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JDL), ordered by most recent decision date.
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