Device Classification Name |
plate, fixation, bone
|
510(k) Number |
K061808 |
Device Name |
DARCO LOCKING BONE PLATE SYSTEM |
Applicant |
DARCO INTERNATIONAL, INC. |
810 MEMORIAL BLVD. |
HUNTINGTON,
WV
25701
|
|
Applicant Contact |
MARK S COOPER |
Correspondent |
DARCO INTERNATIONAL, INC. |
810 MEMORIAL BLVD. |
HUNTINGTON,
WV
25701
|
|
Correspondent Contact |
MARK S COOPER |
Regulation Number | 888.3030
|
Classification Product Code |
|
Date Received | 06/27/2006 |
Decision Date | 08/17/2006 |
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
|
|
|