Device Classification Name |
Intervertebral Fusion Device With Bone Graft, Cervical
|
510(k) Number |
K183557 |
Device Name |
Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS 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, Endoskeleton® TA Vertebral Body Replacement (VBR) Device |
Applicant |
Titan Spine, Inc |
6140 W. Executive Dr., Suite A |
Mequon,
WI
53092
|
|
Applicant Contact |
Jane Rodd |
Correspondent |
MRC/X, LLC |
6075 Poplar Ave. |
Memphis,
TN
38119
|
|
Correspondent Contact |
Christine Scifert |
Regulation Number | 888.3080
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 12/20/2018 |
Decision Date | 02/11/2019 |
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
|
|
|