Device Classification Name |
Plate, Bone
|
510(k) Number |
K201944 |
Device Name |
DePuy Synthes 2.4mm Ti Self-Tapping MatrixMANDIBLE Screws (26-40mm) |
Applicant |
Synthes (USA) Products, LLC |
1301 Goshen Parkway |
West Chester,
PA
19380
|
|
Applicant Contact |
Prem Pisupati |
Correspondent |
Synthes (USA) Products, LLC |
1301 Goshen Parkway |
West Chester,
PA
19380
|
|
Correspondent Contact |
Prem Pisupati |
Regulation Number | 872.4760
|
Classification Product Code |
|
Date Received | 07/13/2020 |
Decision Date | 09/10/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|