FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K Number: K002399
·
Decision Sep 27, 2000
Classifications
1
FEI Numbers
338
Registration Numbers
338
Same Product Code
308
Applicant Total
96
Review Days
51
Basic Information
- Device Name
- MODIFICATION TO CD HORIZON SPINAL SYSTEM
- K Number
- K002399
- 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, INC.
- Date Received
- August 7, 2000
- Decision Date
- September 27, 2000
- Product Code
- MNH
- 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 |
|---|---|---|---|
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MNH), ordered by most recent decision date.
Reliance Spinal Screw System
FDA 510(k)
FDA Class 2
·Orthopedic
CastleLoc Spinal Fixation System
FDA 510(k)
FDA Class 2
·Orthopedic
FixxSure® X-Link
FDA 510(k)
FDA Class 2
·Orthopedic
Spinal fixation system
FDA 510(k)
FDA Class 2
·Orthopedic
ANAX 5.5 Spinal System
FDA 510(k)
FDA Class 2
·Orthopedic
HC Spinal System
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by MEDTRONIC SOFAMOR DANEK, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K141824 | MASTERGRAFT MATRIX EXT; MASTERGRAFT PUTTY, MASTERGRAFT STRIP | Sep 5, 2014 | Substantially Equivalent |
| K140417 | DIVERGENCE MINI-PLATE ANTERIOR CERVICAL FUSION SYSTEM | Jul 9, 2014 | Substantially Equivalent |
| K140449 | CD HORIZON SPINAL SYSTEM | Mar 25, 2014 | Substantially Equivalent |
| K132897 | CLYDESDALE SPINAL SYSTEM | Dec 11, 2013 | Substantially Equivalent |
| K133216 | CRESCENT SPINAL SYSTEM | Nov 22, 2013 | Substantially Equivalent |
| K132700 | PERIMETER INTERBODY FUSION DEVICE | Sep 26, 2013 | Substantially Equivalent |
| K131888 | T2 XVBR SPINAL SYSTEM, T2 ALTITUDE EXPANDABLE CORPECTOMY DEVICE | Sep 23, 2013 | Substantially Equivalent |
| K123027 | CAPSTONE(R) SPINAL SYSTEM | Jul 25, 2013 | Substantially Equivalent |
| K122037 | ANATOMIC PEEK CERVICAL FUSION SYSTEM CORNERSTONE PSR CERVICAL FUSION SYSTEM PEEK PREVAIL CERVICAL INTERBODY DEVICE CAPST | Mar 22, 2013 | Substantially Equivalent |
| K122513 | CLEARED UNDER GRAFTON II EDBM | Mar 6, 2013 | Substantially Equivalent |