Device Classification Name |
Appliance, Fixation, Spinal Intervertebral Body
|
510(k) Number |
K122497 |
Device Name |
ASFORA ANTERIOR CERVICAL PLATE SYSTEM, ONE LEVEL, 14MM ASFORA ANTERIOR CERVICAL PLATE SYSTEM, ONE LEVEL, 16MM |
Applicant |
MEDICAL DESIGN LLC. |
6709 S. MINNESOTA AVE. STE 204 |
SIOUX FALLS,
SD
57108 -2593
|
|
Applicant Contact |
KRISTI VONDRA |
Correspondent |
MEDICAL DESIGN LLC. |
6709 S. MINNESOTA AVE. STE 204 |
SIOUX FALLS,
SD
57108 -2593
|
|
Correspondent Contact |
KRISTI VONDRA |
Regulation Number | 888.3060
|
Classification Product Code |
|
Date Received | 08/16/2012 |
Decision Date | 10/15/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|