Device Classification Name |
Orthosis, Spondylolisthesis Spinal Fixation
|
510(k) Number |
K060118 |
Device Name |
SSP PEDICLE SCREW SYSTEM |
Applicant |
SPECIALTY SPINE PRODUCTS, LLC |
11234 EL CAMINO REAL |
SUITE 200 |
SAN DIEGO,
CA
92130
|
|
Applicant Contact |
FLOYD G LARSON |
Correspondent |
SPECIALTY SPINE PRODUCTS, LLC |
11234 EL CAMINO REAL |
SUITE 200 |
SAN DIEGO,
CA
92130
|
|
Correspondent Contact |
FLOYD G LARSON |
Regulation Number | 888.3070
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 01/17/2006 |
Decision Date | 06/08/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|