Device Classification Name |
plate, bone
|
510(k) Number |
K062789 |
FOIA Releasable 510(k) |
K062789
|
Device Name |
SYNTHES (USA) RAPID RESORBABLE FIXATION SYSTEM |
Applicant |
SYNTHES (USA) |
1230 WILSON DRIVE |
WEST CHESTER,
PA
19380
|
|
Applicant Contact |
JEFFREY DOW |
Correspondent |
SYNTHES (USA) |
1230 WILSON DRIVE |
WEST CHESTER,
PA
19380
|
|
Correspondent Contact |
JEFFREY DOW |
Regulation Number | 872.4760
|
Classification Product Code |
|
Date Received | 09/18/2006 |
Decision Date | 02/27/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|