Device Classification Name |
Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
|
510(k) Number |
K061677 |
Device Name |
SOLAR PUREFIX HA SHOULDER |
Applicant |
HOWMEDICA OSTEONICS CORP |
325 CORPORATE DR. |
MAHWAH,
NJ
07430
|
|
Applicant Contact |
TIFFANI ROGERS |
Correspondent |
HOWMEDICA OSTEONICS CORP |
325 CORPORATE DR. |
MAHWAH,
NJ
07430
|
|
Correspondent Contact |
TIFFANI ROGERS |
Regulation Number | 888.3690
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 06/15/2006 |
Decision Date | 07/10/2006 |
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
|
|
|