Device Classification Name |
screw, fixation, bone
|
510(k) Number |
K230744 |
Device Name |
Acumed Acutrak 3 Headless Compression Screw System |
Applicant |
Acumed LLC |
5885 NE Cornelius Pass Road |
Hillsboro,
OR
97124
|
|
Applicant Contact |
Phillip Saddik |
Correspondent |
Acumed LLC |
5885 NE Cornelius Pass Road |
Hillsboro,
OR
97124
|
|
Correspondent Contact |
Phillip Saddik |
Regulation Number | 888.3040
|
Classification Product Code |
|
Date Received | 03/17/2023 |
Decision Date | 06/09/2023 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|