Device Classification Name |
Appliance, Fixation, Spinal Intervertebral Body
|
510(k) Number |
K121862 |
Device Name |
REX ANTERIOR CERVICAL PLATE SYSTEM |
Applicant |
DIO MEDICAL CO., LTD. |
325 N. PUENTE ST |
UNIT B |
BREA,
CA
92821
|
|
Applicant Contact |
APRIL LEE |
Correspondent |
DIO MEDICAL CO., LTD. |
325 N. PUENTE ST |
UNIT B |
BREA,
CA
92821
|
|
Correspondent Contact |
APRIL LEE |
Regulation Number | 888.3060
|
Classification Product Code |
|
Date Received | 06/26/2012 |
Decision Date | 10/31/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|