Device Classification Name |
thoracolumbosacral pedicle screw system
|
510(k) Number |
K121316 |
Device Name |
LANX SPINAL FIZATION SYSTEM |
Applicant |
LANX, INC. |
310 INTERLOCKEN PARKWAY |
SUITE 120 |
BROOMFIELD,
CO
80021
|
|
Applicant Contact |
WILLIAM SANDUL |
Correspondent |
LANX, INC. |
310 INTERLOCKEN PARKWAY |
SUITE 120 |
BROOMFIELD,
CO
80021
|
|
Correspondent Contact |
WILLIAM SANDUL |
Regulation Number | 888.3070
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 05/02/2012 |
Decision Date | 09/10/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|