Device Classification Name |
Prosthesis, Elbow, Hemi-, Radial, Polymer
|
510(k) Number |
K112030 |
Device Name |
SYNTHES RADIAL HEAD PROSTHESIS SYSTEM |
Applicant |
SYNTHES USA, LLC |
1301 Goshen Parkway |
West Chester,
PA
19380
|
|
Applicant Contact |
ANGELA F LASSANDRO |
Correspondent |
SYNTHES USA, LLC |
1301 Goshen Parkway |
West Chester,
PA
19380
|
|
Correspondent Contact |
ANGELA F LASSANDRO |
Regulation Number | 888.3170
|
Classification Product Code |
|
Date Received | 07/15/2011 |
Decision Date | 06/19/2012 |
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
|
|
|