Device Classification Name |
Intervertebral Fusion Device With Integrated Fixation, Lumbar
|
510(k) Number |
K113285 |
Device Name |
LDR SPINE USA AVENUE L INTERBODY FUSION |
Applicant |
LDR SPINE USA INC. |
13785 RESEARCH BOULEVARD |
SUITE 200 |
AUSTIN,
TX
78750
|
|
Applicant Contact |
MARITZA ELIAS |
Correspondent |
LDR SPINE USA INC. |
13785 RESEARCH BOULEVARD |
SUITE 200 |
AUSTIN,
TX
78750
|
|
Correspondent Contact |
MARITZA ELIAS |
Regulation Number | 888.3080
|
Classification Product Code |
|
Date Received | 11/07/2011 |
Decision Date | 07/26/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|