Device Classification Name |
Intervertebral Fusion Device With Bone Graft, Lumbar
|
510(k) Number |
K103034 |
Device Name |
GENESYS SPINE INTERBODY FUSION SYSTEM |
Applicant |
GENESYS SPINE |
1250 CAPITAL OF TEXAS HWY SO. |
BUILDING THREE, SUITE 600 |
AUSTIN,
TX
78746
|
|
Applicant Contact |
JOSH KAUFMANN |
Correspondent |
GENESYS SPINE |
1250 CAPITAL OF TEXAS HWY SO. |
BUILDING THREE, SUITE 600 |
AUSTIN,
TX
78746
|
|
Correspondent Contact |
JOSH KAUFMANN |
Regulation Number | 888.3080
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 10/13/2010 |
Decision Date | 12/10/2010 |
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
|
|
|