FDA 510(k)
Substantially Equivalent
🇺🇸 United States
KIRSCHNER PROXIMAL FEMUR TOTAL HIP SYSTEM
K Number: K861826
·
Decision Aug 7, 1986
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
76
Review Days
87
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Basic Information
- Device Name
- KIRSCHNER PROXIMAL FEMUR TOTAL HIP SYSTEM
- K Number
- K861826
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- Kirschner Medical Corp.
- Date Received
- May 12, 1986
- Decision Date
- August 7, 1986
- Advisory Committee
- Unknown
- Review Advisory Committee
- OR
- Third Party
- N
Other Clearances by Kirschner Medical Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K940537 | KIRSCHNER(R) MODULAR II-C(TM) TOTAL SHOULDER SYSTEM | Aug 29, 1995 | Substantially Equivalent |
| K936274 | KIRSCHNER PERFORMANCE POSTERIOR STABILIZED TOTAL KNEE SYSTEM | Jan 18, 1995 | Substantially Equivalent |
| K942891 | SUMMIT TOTAL HIP SYSTEM | Nov 2, 1994 | Substantially Equivalent |
| K941486 | INTEGRITY TOTAL HIP SYSTEM, NON-POROUS | Sep 20, 1994 | Substantially Equivalent |
| K933843 | LINE EXTENSION FOR KIRSCHNER PERFORMANCE TOTAL KNEE SYSTEM, POROUS COATED | Aug 5, 1994 | Substantially Equivalent |
| K935951 | KIRSCHNER C-2 OSTEOCAP TOTAL HIP SYSTEM | Jul 18, 1994 | Substantially Equivalent |
| K935206 | KIRSCHNER INTEGRITY ACETABULAR CUP MODIFICATION | Jul 13, 1994 | Substantially Equivalent |
| K934589 | KIRSCHNER PERFORMANCE TOTAL KNEE SYSTEM POROUS COATED | Jul 13, 1994 | Substantially Equivalent for Some Indications |
| K934694 | KIRSCHNER ZIRCONIA FEMORAL HEAD | May 18, 1994 | Substantially Equivalent |
| K920188 | THREADED PINS | May 12, 1993 | Substantially Equivalent |