Device Classification Name |
Intervertebral Fusion Device With Integrated Fixation, Cervical
|
510(k) Number |
K153122 |
Device Name |
Endoskeleton(r) TCS System |
Applicant |
TITAN SPINE, LLC |
6140 W. EXECUTIVE DRIVE, SUITE A |
MEQUON,
WI
53092
|
|
Applicant Contact |
Jane Rodd |
Correspondent |
Memphis Regulatory Consulting, LLC |
3416 Roxee Run Cove |
Bartlett,
TN
38133
|
|
Correspondent Contact |
Christine Scifert |
Regulation Number | 888.3080
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 10/29/2015 |
Decision Date | 12/14/2015 |
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
|
|
|