Device Classification Name |
Appliance, Fixation, Spinal Intervertebral Body
|
510(k) Number |
K043151 |
Device Name |
MODIFICATION TO: CD HORIZON SPINAL SYSTEM |
Applicant |
MEDTRONIC SOFAMOR DANEK |
1800 PYRAMID PLACE |
MEMPHIS,
TN
38132
|
|
Applicant Contact |
RICHARD TREHARNE |
Correspondent |
MEDTRONIC SOFAMOR DANEK |
1800 PYRAMID PLACE |
MEMPHIS,
TN
38132
|
|
Correspondent Contact |
RICHARD TREHARNE |
Regulation Number | 888.3060
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 11/15/2004 |
Decision Date | 02/01/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|