Device Classification Name |
Thoracolumbosacral Pedicle Screw System
|
510(k) Number |
K083089 |
Device Name |
NEWPORT SPINAL SYSTEM |
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 | 888.3070
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 10/16/2008 |
Decision Date | 01/13/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|