Device Classification Name |
condylar plate fixation implant
|
510(k) Number |
K110354 |
Device Name |
4.5MM VA-LCP CURVED CONDYLAR PLATE SYSTEM |
Applicant |
SYNTHES USA |
1301 GOSHEN PKWY |
WEST CHESTER,
PA
19380
|
|
Applicant Contact |
THOMAS N SHEA |
Correspondent |
SYNTHES USA |
1301 GOSHEN PKWY |
WEST CHESTER,
PA
19380
|
|
Correspondent Contact |
THOMAS N SHEA |
Regulation Number | 888.3030
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 02/07/2011 |
Decision Date | 03/04/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|