Device Classification Name |
orthosis, spinal pedicle fixation
|
510(k) Number |
K052847 |
Device Name |
CAPLESS PEDICLE SCREW SYSTEM |
Applicant |
X-SPINE SYSTEMS, INC. |
11234 EL CAMINO REAL |
SUITE 200 |
SAN DIEGO,
CA
92130
|
|
Applicant Contact |
FLOYD G LARSON |
Correspondent |
X-SPINE SYSTEMS, INC. |
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 | 10/07/2005 |
Decision Date | 12/12/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|