Device Classification Name |
Intervertebral Fusion Device With Bone Graft, Lumbar
|
510(k) Number |
K120293 |
Device Name |
SPINEOLOGY PEEK LUMBAR INTERBODY FUSION DRIVE |
Applicant |
SPINEOLOGY, INC. |
7800 3RD ST N., SUITE 600 |
ST. PAUL,
MN
55128
|
|
Applicant Contact |
BRYAN BECKER |
Correspondent |
SPINEOLOGY, INC. |
7800 3RD ST N., SUITE 600 |
ST. PAUL,
MN
55128
|
|
Correspondent Contact |
BRYAN BECKER |
Regulation Number | 888.3080
|
Classification Product Code |
|
Date Received | 01/31/2012 |
Decision Date | 02/29/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|