Device Classification Name |
rod, fixation, intramedullary and accessories
|
510(k) Number |
K031438 |
Device Name |
ACUMED SMALL BONE LOCKING ROD SYSTEM II |
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 | 888.3020
|
Classification Product Code |
|
Date Received | 05/06/2003 |
Decision Date | 07/17/2003 |
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
|
|
|