Device Classification Name |
screw, fixation, bone
|
510(k) Number |
K192745 |
Device Name |
DePuy Synthes Trauma Screws |
Applicant |
Synthes (USA) Products LLC / DePuy Orthopaedics Inc |
1301 Goshen Parkway |
West Chester,
PA
19380
|
|
Applicant Contact |
Keith Knapp |
Correspondent |
Synthes (USA) Products LLC / DePuy Orthopaedics Inc |
1301 Goshen Parkway |
West Chester,
PA
19380
|
|
Correspondent Contact |
Keith Knapp |
Regulation Number | 888.3040
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 09/30/2019 |
Decision Date | 11/26/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|