Device Classification Name |
Spinal Vertebral Body Replacement Device
|
510(k) Number |
K071726 |
Device Name |
ZUMA |
Applicant |
SEASPINE, INC. |
2302 LA MIRADA DR. |
VISTA,
CA
92081 -7862
|
|
Applicant Contact |
ETHEL BERNAL |
Correspondent |
SEASPINE, INC. |
2302 LA MIRADA DR. |
VISTA,
CA
92081 -7862
|
|
Correspondent Contact |
ETHEL BERNAL |
Regulation Number | 888.3060
|
Classification Product Code |
|
Date Received | 06/25/2007 |
Decision Date | 10/23/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|