Device Classification Name |
Orthosis, Spinal Pedicle Fixation
|
510(k) Number |
K033772 |
Device Name |
SHIRAZ-JAVA SPINAL FIXATION 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 | 888.3070
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 12/03/2003 |
Decision Date | 01/27/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|