Device Classification Name |
Intervertebral Fusion Device With Bone Graft, Cervical
|
510(k) Number |
K192018 |
Device Name |
Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic Interbody Fusion Device, Endoskeleton TO Interbody Fusion Device, Endoskeleton TT Interbody Fusion Device, Endoskeleton TC Interbody Fusion Device, Endoskeleton TCS Interbody Fusion Device, Endoskeleton TL Interbody Fusion Device |
Applicant |
Titan Spine, Inc |
6140 West Executive Dr., Suite A |
Mequon,
WI
53092
|
|
Applicant Contact |
Jane Rodd |
Correspondent |
Titan Spine, Inc |
6140 West Executive Dr., Suite A |
Mequon,
WI
53092
|
|
Correspondent Contact |
Christine Scifert |
Regulation Number | 888.3080
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 07/29/2019 |
Decision Date | 08/16/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|