Device Classification Name |
spinal vertebral body replacement device
|
510(k) Number |
K080728 |
Device Name |
LDR SPINE ROI-C IMPLANT |
Applicant |
LDR SPINE USA |
4030 WEST BRAKER LANE |
SUITE 360 |
AUSTIN,
TX
78759
|
|
Applicant Contact |
NOAH BARTSCH |
Correspondent |
LDR SPINE USA |
4030 WEST BRAKER LANE |
SUITE 360 |
AUSTIN,
TX
78759
|
|
Correspondent Contact |
NOAH BARTSCH |
Regulation Number | 888.3060
|
Classification Product Code |
|
Date Received | 03/14/2008 |
Decision Date | 05/29/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|