FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IMPLEX HEP ACETABULAR REVISION CUP, CEMENTED OR CEMENTLESS MODEL A-240 SYSTEM
K Number: K980486
·
Decision Apr 14, 1998
Classifications
1
FEI Numbers
231
Registration Numbers
231
Same Product Code
560
Applicant Total
65
Review Days
64
Basic Information
- Device Name
- IMPLEX HEP ACETABULAR REVISION CUP, CEMENTED OR CEMENTLESS MODEL A-240 SYSTEM
- K Number
- K980486
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3350
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- IMPLEX CORP.
- Date Received
- February 9, 1998
- Decision Date
- April 14, 1998
- Product Code
- JDI
- 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 |
|---|---|---|---|
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | FDA class 2 | Orthopedic |
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