Device Classification Name |
Intervertebral Fusion Device With Bone Graft, Lumbar
|
510(k) Number |
K113527 |
Device Name |
OPTICAGE INTERBODY FUSION DEVICE |
Applicant |
INTERVENTIONAL SPINE, INC. |
13700 ALTON PKWY., SUITE 160 |
IRVINE,
CA
92618
|
|
Applicant Contact |
JANE METCALF |
Correspondent |
INTERVENTIONAL SPINE, INC. |
13700 ALTON PKWY., SUITE 160 |
IRVINE,
CA
92618
|
|
Correspondent Contact |
JANE METCALF |
Regulation Number | 888.3080
|
Classification Product Code |
|
Date Received | 11/30/2011 |
Decision Date | 01/20/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|