FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODIFICATION TO:CD HORIZON SPINAL SYSTEM
K Number: K052747
·
Decision Oct 28, 2005
Classifications
1
FEI Numbers
413
Registration Numbers
413
Same Product Code
873
Applicant Total
145
Review Days
28
Basic Information
- Device Name
- MODIFICATION TO:CD HORIZON SPINAL SYSTEM
- K Number
- K052747
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3070
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- MEDTRONIC SOFAMOR DANEK
- Date Received
- September 30, 2005
- Decision Date
- October 28, 2005
- Product Code
- NKB
- 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 |
|---|---|---|---|
| NKB | Thoracolumbosacral Pedicle Screw System | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (NKB), ordered by most recent decision date.
KHEIRON® Spinal Fixation System, including patient specific K-ROD
FDA 510(k)
FDA Class 2
·Orthopedic
Momentum® Posterior Spinal Fixation System
FDA 510(k)
FDA Class 2
·Orthopedic
Virata Spinal Fixation System
FDA 510(k)
FDA Class 2
·Orthopedic
RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation Instruments
FDA 510(k)
FDA Class 2
·Orthopedic
Annex® 2 Adjacent Level System
FDA 510(k)
FDA Class 2
·Orthopedic
COLONNADE Posterior Screw Fixation System
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by MEDTRONIC SOFAMOR DANEK
| K Number | Device Name | ||
|---|---|---|---|
| K140276 | CD HORIZON SPINAL SYSTEM | Mar 13, 2014 | Substantially Equivalent |
| K123246 | CD HORIZON SPIRE Z SPINAL SYSTEM | Nov 16, 2012 | Unknown |
| K121982 | SOVEREIGN SPINAL SYSTEM | Jul 26, 2012 | Substantially Equivalent |
| K110472 | SI-FIX SACROILIAC JOINT FUSION SYSTEM | May 29, 2012 | Substantially Equivalent |
| K113529 | CD HORIZON VOYAGER SPINAL SYSTEM | Feb 9, 2012 | Unknown |
| K113252 | PEEK PREVAIL CERVICAL INTERBODY DEVICE | Jan 17, 2012 | Substantially Equivalent |
| K111457 | CD HORIZON SPINAL SYSTEM | Sep 15, 2011 | Unknown |
| K111525 | PERIMETER INTERBODY FUSION DEVICE | Aug 24, 2011 | Substantially Equivalent |
| K103731 | CAPSTONE R SPINAL SYSTEM | Jul 18, 2011 | Substantially Equivalent |
| K110676 | TSRH SPINAL SYSTEM | May 23, 2011 | Substantially Equivalent |