FDA 510(k)
FDA class 3
Substantially Equivalent for Some Indications
🇺🇸 United States
S.A.F. ACETABULAR CUP WITH POROUS COATING
K Number: K896614
·
Decision Jan 9, 1990
Classifications
1
FEI Numbers
50
Registration Numbers
50
Same Product Code
44
Applicant Total
2
Review Days
49
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Basic Information
- Device Name
- S.A.F. ACETABULAR CUP WITH POROUS COATING
- K Number
- K896614
- Device Class
- FDA class 3
- Clearance Type
- Traditional
- Regulation Number
- 888.3320
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent for Some Indications
- Applicant
- Synergy Orthopaedics Intl., Inc.
- Date Received
- November 21, 1989
- Decision Date
- January 9, 1990
- 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
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Other Clearances by Synergy Orthopaedics Intl., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K895157 | S.A.F. ACETABULAR CUP | Dec 1, 1989 | Substantially Equivalent |