Device Classification Name |
Intervertebral Fusion Device With Integrated Fixation, Lumbar
|
510(k) Number |
K163269 |
Device Name |
Endoskeleton(R) TAS Interbody Fusion Device / Endoskeleton(R) TAS Hyperlordotic Interbody Fusion Device |
Applicant |
TITAN SPINE, LLC |
6140 W. EXECUTIVE DR |
STE A |
MEQUON,
WI
53092
|
|
Applicant Contact |
JANE RODD |
Correspondent |
MRC-X, LLC |
3416 ROXEE RUN COVE |
BARTLETT,
TN
38133
|
|
Correspondent Contact |
CHRISTINE SCIFERT |
Regulation Number | 888.3080
|
Classification Product Code |
|
Date Received | 11/21/2016 |
Decision Date | 04/13/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|