Device Classification Name |
appliance, fixation, spinal intervertebral body
|
510(k) Number |
K033965 |
Device Name |
SHIRAZ-ANTERIOR SYSTEM |
Applicant |
SPINE NEXT AMERICA |
104 GREENWOOD CREEK ROAD |
QUEENSTOWN,
MD
21658
|
|
Applicant Contact |
DIANE JOHNSON |
Correspondent |
SPINE NEXT AMERICA |
104 GREENWOOD CREEK ROAD |
QUEENSTOWN,
MD
21658
|
|
Correspondent Contact |
DIANE JOHNSON |
Regulation Number | 888.3060
|
Classification Product Code |
|
Date Received | 12/22/2003 |
Decision Date | 03/04/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|