Device Classification Name |
plate, fixation, bone
|
510(k) Number |
K043263 |
Device Name |
TRIMED OSTEOTOMY PLATE |
Applicant |
TRIMED, INC. |
28337 MAITLAND LANE |
SAUGUS,
CA
91350
|
|
Applicant Contact |
KELLI ANDERSON |
Correspondent |
TRIMED, INC. |
28337 MAITLAND LANE |
SAUGUS,
CA
91350
|
|
Correspondent Contact |
KELLI ANDERSON |
Regulation Number | 888.3030
|
Classification Product Code |
|
Date Received | 11/24/2004 |
Decision Date | 01/14/2005 |
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
|
|
|