Device Classification Name |
Intervertebral Fusion Device With Bone Graft, Lumbar
|
510(k) Number |
K121581 |
Device Name |
BOX PEEK VBR SYSTEM, |
Applicant |
INNOVASIS, INC. |
614 EAST 3900 SOUTH |
SALT LAKE CITY,
UT
84107
|
|
Applicant Contact |
MARSHALL C MCCARTY |
Correspondent |
INNOVASIS, INC. |
614 EAST 3900 SOUTH |
SALT LAKE CITY,
UT
84107
|
|
Correspondent Contact |
MARSHALL C MCCARTY |
Regulation Number | 888.3080
|
Classification Product Code |
|
Date Received | 05/30/2012 |
Decision Date | 10/17/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|