FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
KIRSCHNER(R) MODULAR II-C(TM) TOTAL SHOULDER SYSTEM
K Number: K940537
·
Decision Aug 29, 1995
Classifications
1
FEI Numbers
155
Registration Numbers
155
Same Product Code
70
Applicant Total
76
Review Days
568
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Basic Information
- Device Name
- KIRSCHNER(R) MODULAR II-C(TM) TOTAL SHOULDER SYSTEM
- K Number
- K940537
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3650
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Kirschner Medical Corp.
- Date Received
- February 7, 1994
- Decision Date
- August 29, 1995
- Product Code
- KWT
- 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 |
|---|---|---|---|
| KWT | Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | FDA class 2 | Orthopedic |
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Other Clearances by Kirschner Medical Corp.
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| K921837 | MEDICAM 900 INSUFFLATOR WITH ACCESSORIES | Feb 5, 1993 | Substantially Equivalent |