Device Classification Name |
Intervertebral Fusion Device With Bone Graft, Lumbar
|
510(k) Number |
K112095 |
Device Name |
ACCULIF TL-PEEK IBF CAGE |
Applicant |
COALIGN INNOVATIONS, INC. |
1331 H STREET NW |
12TH FLOOR |
WASHINGTON,
DC
20005
|
|
Applicant Contact |
JUSTIN EGGLETON |
Correspondent |
COALIGN INNOVATIONS, INC. |
1331 H STREET NW |
12TH FLOOR |
WASHINGTON,
DC
20005
|
|
Correspondent Contact |
JUSTIN EGGLETON |
Regulation Number | 888.3080
|
Classification Product Code |
|
Date Received | 07/22/2011 |
Decision Date | 12/01/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|