Device Classification Name |
cerclage, fixation
|
510(k) Number |
K081205 |
Device Name |
SYNTHES (USA) 5.0MM/7.3MM CRIMP POSITIONING PINS |
Applicant |
SYNTHES (USA) |
1301 GOSHEN PKWY |
WEST CHESTER,
PA
19380
|
|
Applicant Contact |
KARL J NITTINGER |
Correspondent |
SYNTHES (USA) |
1301 GOSHEN PKWY |
WEST CHESTER,
PA
19380
|
|
Correspondent Contact |
KARL J NITTINGER |
Regulation Number | 888.3010
|
Classification Product Code |
|
Date Received | 04/29/2008 |
Decision Date | 07/01/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|