Device Classification Name |
plate, fixation, bone
|
510(k) Number |
K102998 |
Device Name |
CONGRUENT BONE PLATE SYSTEM |
Applicant |
ACUMED LLC |
5885 NW CORNELIUS PASS RD. |
HILLSBORO,
OR
97124 -9432
|
|
Applicant Contact |
ED BOEHMER |
Correspondent |
ACUMED LLC |
5885 NW CORNELIUS PASS RD. |
HILLSBORO,
OR
97124 -9432
|
|
Correspondent Contact |
ED BOEHMER |
Regulation Number | 888.3030
|
Classification Product Code |
|
Date Received | 10/08/2010 |
Decision Date | 01/04/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|