Device Classification Name |
Screw, Fixation, Bone
|
510(k) Number |
K033639 |
Device Name |
ACUMED LOWER EXTREMITY CONGRUENT 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 | 888.3040
|
Classification Product Code |
|
Date Received | 11/20/2003 |
Decision Date | 01/15/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|