Device Classification Name |
thoracolumbosacral pedicle screw system
|
510(k) Number |
K091219 |
Device Name |
DEL MAR MONOAXIAL PEDICLE SCREW SYSTEM |
Applicant |
ALLEZ SPINE, LLC |
2301 DUPONT DRIVE, SUITE 510 |
IRVINE,
CA
92612
|
|
Applicant Contact |
HARTMUT LOCH |
Correspondent |
ALLEZ SPINE, LLC |
2301 DUPONT DRIVE, SUITE 510 |
IRVINE,
CA
92612
|
|
Correspondent Contact |
HARTMUT LOCH |
Regulation Number | 888.3070
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 04/27/2009 |
Decision Date | 07/09/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|