Device Classification Name |
Intervertebral Fusion Device With Bone Graft, Lumbar
|
510(k) Number |
K182987 |
Device Name |
Genesys Spine 3DP Lumbar Interbody System |
Applicant |
Genesys Spine |
1250 South Capital of Texas Highway, Building 3 Suite 600 |
Austin,
TX
78746
|
|
Applicant Contact |
William W. Sowers |
Correspondent |
Genesys Spine |
1250 South Capital of Texas Highway, Building 3 Suite 600 |
Austin,
TX
78746
|
|
Correspondent Contact |
William W. Sowers |
Regulation Number | 888.3080
|
Classification Product Code |
|
Date Received | 10/29/2018 |
Decision Date | 12/12/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|