Device Classification Name |
Prosthesis, Elbow, Semi-Constrained, Cemented
|
510(k) Number |
K070236 |
Device Name |
SBI LATERAL RADIO CAPITELLUM |
Applicant |
SMALL BONE INNOVATIONS, INC. |
505 PARK AVENUE, 14TH FLOOR |
NEWYORK,
NY
|
|
Applicant Contact |
ROBERT HOEHN |
Correspondent |
SMALL BONE INNOVATIONS, INC. |
505 PARK AVENUE, 14TH FLOOR |
NEWYORK,
NY
|
|
Correspondent Contact |
ROBERT HOEHN |
Regulation Number | 888.3160
|
Classification Product Code |
|
Date Received | 01/25/2007 |
Decision Date | 02/21/2007 |
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
|
|
|