FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CONTOURED ARTICULAR PROSTHESIS (CAP) FEMORAL HEAD RESURFACING SYSTEM
K Number: K021549
·
Decision Aug 1, 2002
Classifications
1
FEI Numbers
26
Registration Numbers
26
Same Product Code
22
Applicant Total
6
Review Days
80
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
- CONTOURED ARTICULAR PROSTHESIS (CAP) FEMORAL HEAD RESURFACING SYSTEM
- K Number
- K021549
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3400
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Std Mfg., Inc.
- Date Received
- May 13, 2002
- Decision Date
- August 1, 2002
- Product Code
- KXA
- 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 |
|---|---|---|---|
| KXA | Prosthesis, Hip, Femoral, Resurfacing | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KXA), ordered by most recent decision date.
Biocore9 Femoral Head Resurfacing Component
FDA 510(k)
FDA Class 2
·Orthopedic
CORMET CEMENTLESS RESURFACING FEMORAL HEAD
FDA 510(k)
FDA Class 2
·Orthopedic
CONSERVE PRESSFIT FEMORAL COMPONENT
FDA 510(k)
FDA Class 2
·Orthopedic
RECAP HA PRESS-FIT FEMORAL RESURFACING HEAD
FDA 510(k)
FDA Class 2
·Orthopedic
DUROM HIP RESURFACING SYSTEM, FEMORAL COMPONENTS
FDA 510(k)
FDA Class 2
·Orthopedic
CONSERVE FEMORAL RESURFACING COMPONENT
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by Std Mfg., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K023096 | CONTOURED ARTICULAR PROSTHESIS (CAP) HUMERAL HEAD RESURFACING SYSTEM | Apr 10, 2003 | Substantially Equivalent |
| K012362 | MODIFICATION TO VASCULAR CLOSURE DEVICE | Aug 23, 2001 | Substantially Equivalent |
| K003169 | VASCULAR CLOSURE DEVICE | Dec 8, 2000 | Substantially Equivalent |
| K000608 | SUCTION VASCULAR STAPLER AND IMPLANTABLE STAPLE SYSTEM | Mar 7, 2000 | Substantially Equivalent |
| K930427 | STD IRRIGATION PUMP | Jun 1, 1993 | Substantially Equivalent |