Device Classification Name |
appliance, fixation, nail/blade/plate combination, multiple component
|
510(k) Number |
K092190 |
Device Name |
SYNTHES DISTRACTION OSTEOGENESIS SYSTEM, MR CONDITIONAL WITH EXPANDED INDICATIONS |
Applicant |
SYNTHES (USA) |
1301 GOSHEN PKWY. |
WEST CHESTER,
PA
19380
|
|
Applicant Contact |
JILL R YELTON |
Correspondent |
SYNTHES (USA) |
1301 GOSHEN PKWY. |
WEST CHESTER,
PA
19380
|
|
Correspondent Contact |
JILL R YELTON |
Regulation Number | 888.3030
|
Classification Product Code |
|
Date Received | 07/21/2009 |
Decision Date | 05/11/2010 |
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
|
|
|