Device Classification Name |
plate, fixation, bone
|
510(k) Number |
K131764 |
Device Name |
ACUMED WRIST SPANNING PLATE |
Applicant |
ACUMED LLC |
5885 NW Cornelius Pass Rd |
HILLSBORO,
OR
97124
|
|
Applicant Contact |
NATHAN WOLF |
Correspondent |
ACUMED LLC |
5885 NW Cornelius Pass Rd |
HILLSBORO,
OR
97124
|
|
Correspondent Contact |
NATHAN WOLF |
Regulation Number | 888.3030
|
Classification Product Code |
|
Date Received | 06/17/2013 |
Decision Date | 09/05/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|