Device Classification Name |
plate, fixation, bone
|
510(k) Number |
K070946 |
Device Name |
SYNTHES LCP DIAPHYSEAL-METAPHYSEAL (DIA-META) VOLAR DISTAL RADIUS PLATES |
Applicant |
SYNTHES (USA) |
1301 GOSHEN PKWY |
WEST CHESTER,
PA
19380
|
|
Applicant Contact |
SHERI L MUSGNUNG |
Correspondent |
SYNTHES (USA) |
1301 GOSHEN PKWY |
WEST CHESTER,
PA
19380
|
|
Correspondent Contact |
SHERI L MUSGNUNG |
Regulation Number | 888.3030
|
Classification Product Code |
|
Date Received | 04/04/2007 |
Decision Date | 06/06/2007 |
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
|
|
|