Device Classification Name |
Prosthesis, Elbow, Semi-Constrained, Cemented
|
510(k) Number |
K102180 |
Device Name |
RHEAD RADIAL HEAD EXTENDED STEMS |
Applicant |
SMALL BONE INNOVATIONS, INC. |
1380 S. PENNSYLVANIA AVE. |
MORRISVILLE,
PA
19067
|
|
Applicant Contact |
JAMES O'CONNOR |
Correspondent |
SMALL BONE INNOVATIONS, INC. |
1380 S. PENNSYLVANIA AVE. |
MORRISVILLE,
PA
19067
|
|
Correspondent Contact |
JAMES O'CONNOR |
Regulation Number | 888.3160
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 08/02/2010 |
Decision Date | 12/20/2010 |
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
|
|
|