FDA 510(k)
FDA class 3
Substantially Equivalent
🇺🇸 United States
THREADED PINS
K Number: K920188
·
Decision May 12, 1993
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
0
Applicant Total
76
Review Days
483
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Basic Information
- Device Name
- THREADED PINS
- K Number
- K920188
- Device Class
- FDA class 3
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Kirschner Medical Corp.
- Date Received
- January 15, 1992
- Decision Date
- May 12, 1993
- Product Code
- MBJ
- Advisory Committee
- Unknown
- 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 |
|---|---|---|---|
| MBJ | Fastener, Fixation, Biodegradable, Hard Tissue | FDA class 3 | Unknown |
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 |
| K921837 | MEDICAM 900 INSUFFLATOR WITH ACCESSORIES | Feb 5, 1993 | Substantially Equivalent |