Device Classification Name |
filler, bone void, osteoinduction (w/o human growth factor)
|
510(k) Number |
K143547 |
Device Name |
Vivorte Trabexus EB |
Applicant |
VIVORTE, INC |
1044 EAST CHESTNUT STREET |
LOUISVILLE,
KY
40204
|
|
Applicant Contact |
Robert Burden |
Correspondent |
Peoples & Associates |
5010 Lodge Pole Lane |
Fort Wayne,
IN
46814
|
|
Correspondent Contact |
Stephen J Peoples |
Regulation Number | 888.3045
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 12/15/2014 |
Decision Date | 01/14/2015 |
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
|
|
|