Device Classification Name |
Plate, Bone
|
510(k) Number |
K202918 |
Device Name |
OsteoSync™ Ti Dental Mesh |
Applicant |
Sites Medical, LLC |
5865 E State Road 14 |
Columbia City,
IN
46725
|
|
Applicant Contact |
Greg Stalcup |
Correspondent |
BackRoads Consulting |
PO BOX 566 |
Chesterland,
OH
44026
|
|
Correspondent Contact |
Karen E Warden |
Regulation Number | 872.4760
|
Classification Product Code |
|
Date Received | 09/29/2020 |
Decision Date | 07/14/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|