Device Classification Name |
thoracolumbosacral pedicle screw system
|
510(k) Number |
K112931 |
Device Name |
LEUCADIA(TM) MIS PEDICLE SCREW SYSTEM |
Applicant |
PHYGEN, LLC |
2301 DUPONT DRIVE, SUITE 510 |
IRVINE,
CA
92612
|
|
Applicant Contact |
HARTMUT LOCH |
Correspondent |
PHYGEN, 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 | 10/03/2011 |
Decision Date | 11/02/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|