| Device Classification Name |
prosthesis, hip, hemi-, femoral, metal ball |
|||
|---|---|---|---|---|
| 510(k) Number | K111145 | |||
| Device Name | ENDO HEAD | |||
| Applicant |
|
|||
| Applicant Contact | adam gross | |||
| Correspondent |
|
|||
| Correspodent Contact | adam gross | |||
| Regulation Number | 888.3360 | |||
| Classification Product Code |
|
|||
| Date Received | 04/22/2011 | |||
| Decision Date | 08/16/2011 | |||
| Decision |
substantially equivalent (SESE) |
|||
| Regulation Medical Specialty |
Orthopedic |
|||
| 510k Review Panel |
Orthopedic |
|||
| summary |
summary |
|||
| Type | Traditional | |||
| Reviewed by Third Party | No | |||
| Combination Product |
No |