Device Classification Name |
Intervertebral Fusion Device With Bone Graft, Cervical
|
510(k) Number |
K173535 |
Device Name |
Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TAS Hyperlordotic Interbody Fusion Device and Endoskeleton® TCS Interbody Fusion Device |
Applicant |
Titan Spine, LLC |
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 | 11/15/2017 |
Decision Date | 02/13/2018 |
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
|
|
|