Device Classification Name |
prosthesis, shoulder, hemi-, humeral, metallic uncemented
|
510(k) Number |
K001419 |
Device Name |
SOLAR SHOULDER OFFSET HUMERAL HEAD |
Applicant |
HOWMEDICA OSTEONICS CORP. |
59 ROUTE 17 SOUTH |
ALLENDALE,
NJ
07401 -1677
|
|
Applicant Contact |
KAREN ARIEMMA |
Correspondent |
HOWMEDICA OSTEONICS CORP. |
59 ROUTE 17 SOUTH |
ALLENDALE,
NJ
07401 -1677
|
|
Correspondent Contact |
KAREN ARIEMMA |
Regulation Number | 888.3690
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 05/05/2000 |
Decision Date | 07/27/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|