Device Classification Name |
intervertebral fusion device with integrated fixation, cervical
|
510(k) Number |
K142940 |
FOIA Releasable 510(k) |
K142940
|
Device Name |
Endoskeleton TCS System |
Applicant |
TITAN SPINE, LLC |
6140 WEST EXECUTIVE DRIVE, SUITE A |
MEQUON,
WI
53092
|
|
Applicant Contact |
Jane Rodd |
Correspondent |
MEMPHIS REGULATORY CONSULTING, LLC |
3416 ROXEE RUN COVE |
BARTLETTE,
TN
38133
|
|
Correspondent Contact |
Christine Scifert |
Regulation Number | 888.3080
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 10/09/2014 |
Decision Date | 01/28/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|