Device Classification Name |
Orthosis, Spondylolisthesis Spinal Fixation
|
510(k) Number |
K061162 |
Device Name |
BAR PEDICLE SCREW SPINAL FIXATION SYSTEM, MODEL 2020 |
Applicant |
APPLIED SPINE TECHNOLOGIES, INC. |
300 GEORGE ST. |
SUITE 511 |
NEW HAVEN,
CT
06511
|
|
Applicant Contact |
MICHELE LUCEY |
Correspondent |
APPLIED SPINE TECHNOLOGIES, INC. |
300 GEORGE ST. |
SUITE 511 |
NEW HAVEN,
CT
06511
|
|
Correspondent Contact |
MICHELE LUCEY |
Regulation Number | 888.3070
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 04/26/2006 |
Decision Date | 07/26/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|