FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MCAFEE SPINAL SYSTEM FOR POSTERIOR APPLICATIONS
K Number: K912837
·
Decision Aug 26, 1992
Classifications
1
FEI Numbers
330
Registration Numbers
330
Same Product Code
429
Applicant Total
76
Review Days
427
Basic Information
- Device Name
- MCAFEE SPINAL SYSTEM FOR POSTERIOR APPLICATIONS
- K Number
- K912837
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3050
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- KIRSCHNER MEDICAL CORP.
- Date Received
- June 26, 1991
- Decision Date
- August 26, 1992
- Product Code
- KWP
- 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 |
|---|---|---|---|
| KWP | Appliance, Fixation, Spinal Interlaminal | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KWP), ordered by most recent decision date.
LnK Posterior Cervical Fixation System
FDA 510(k)
FDA Class 2
·Orthopedic
OASYS System
FDA 510(k)
FDA Class 2
·Orthopedic
Sure Lok Mini Posterior Cervical/Upper Thoracic System
FDA 510(k)
FDA Class 2
·Orthopedic
Reliance Posterior Cervical-Thoracic System
FDA 510(k)
FDA Class 2
·Orthopedic
Streamline OCT Occipito-Cervico-Thoracic System
FDA 510(k)
FDA Class 2
·Orthopedic
SOLSTICE OCT System
FDA 510(k)
FDA Class 2
·Orthopedic
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 |
| K934589 | KIRSCHNER PERFORMANCE TOTAL KNEE SYSTEM POROUS COATED | Jul 13, 1994 | Substantially Equivalent for Some Indications |
| K935206 | KIRSCHNER INTEGRITY ACETABULAR CUP MODIFICATION | Jul 13, 1994 | Substantially Equivalent |
| K934694 | KIRSCHNER ZIRCONIA FEMORAL HEAD | May 18, 1994 | Substantially Equivalent |
| K920188 | THREADED PINS | May 12, 1993 | Substantially Equivalent |