FDA 510(k)
FDA class 3
Substantially Equivalent
🇺🇸 United States
S.A.F. ACETABULAR CUP
K Number: K895157
·
Decision Dec 1, 1989
Classifications
1
FEI Numbers
53
Registration Numbers
53
Same Product Code
113
Applicant Total
2
Review Days
113
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- S.A.F. ACETABULAR CUP
- K Number
- K895157
- Device Class
- FDA class 3
- Clearance Type
- Traditional
- Regulation Number
- 888.3330
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- Synergy Orthopaedics Intl., Inc.
- Date Received
- August 10, 1989
- Decision Date
- December 1, 1989
- Product Code
- KWA
- 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 |
|---|---|---|---|
| KWA | Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) | FDA class 3 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KWA), ordered by most recent decision date.
PROFEMUR Z REVISION HIP STEM
FDA 510(k)
FDA Class 3
·Orthopedic
DYNASTY BIOFOAM SHELL
FDA 510(k)
FDA Class 3
·Orthopedic
METAL-ON-METAL HIP SYSTEMS-ADDITIONAL CONTRAINDICATIONS
FDA 510(k)
FDA Class 3
·Orthopedic
CONSERVE THIN SHELL
FDA 510(k)
FDA Class 3
·Orthopedic
PRESERVE HIP STEM
FDA 510(k)
FDA Class 3
·Orthopedic
PROFEMUR GLADIATOR HA HIP STEM
FDA 510(k)
FDA Class 3
·Orthopedic
Other Clearances by Synergy Orthopaedics Intl., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K896614 | S.A.F. ACETABULAR CUP WITH POROUS COATING | Jan 9, 1990 | Substantially Equivalent for Some Indications |