Device Classification Name |
appliance, fixation, spinal intervertebral body
|
510(k) Number |
K121791 |
Device Name |
ZOU ANTERIOR LUMBAR PLATE SYSTEM |
Applicant |
CORELINK LLC |
1331 H STREET |
12TH FLOOR |
WASHINGTON,
DC
20005
|
|
Applicant Contact |
JUSTIN EGGLETON |
Correspondent |
CORELINK LLC |
1331 H STREET |
12TH FLOOR |
WASHINGTON,
DC
20005
|
|
Correspondent Contact |
JUSTIN EGGLETON |
Regulation Number | 888.3060
|
Classification Product Code |
|
Date Received | 06/19/2012 |
Decision Date | 11/19/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|