Device Classification Name |
intervertebral fusion device with bone graft, lumbar
|
510(k) Number |
K150395 |
Device Name |
Omega LIF System |
Applicant |
AMENDIA, INC. |
1755 W. OAK PARKWAY |
MARIETTA,
GA
30062
|
|
Applicant Contact |
Bruce Hooper |
Correspondent |
AMENDIA, INC. |
1755 W. OAK PARKWAY |
MARIETTA,
GA
30062
|
|
Correspondent Contact |
Kristen Allen |
Regulation Number | 888.3080
|
Classification Product Code |
|
Date Received | 02/18/2015 |
Decision Date | 08/10/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|