Device Classification Name |
intervertebral fusion device with integrated fixation, lumbar
|
510(k) Number |
K131547 |
Device Name |
LANX FUSION SYSTEM |
Applicant |
LANX, INC. |
310 INTERLOCKEN PARKWAY |
SUITE 120 |
BROOMFIELD,
CO
80021
|
|
Applicant Contact |
Alan Burkholder |
Correspondent |
LANX, INC. |
310 INTERLOCKEN PARKWAY |
SUITE 120 |
BROOMFIELD,
CO
80021
|
|
Correspondent Contact |
Alan Burkholder |
Regulation Number | 888.3080
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 05/29/2013 |
Decision Date | 07/12/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|