Device Classification Name |
prosthesis, hip, hemi-, femoral, metal ball
|
510(k) Number |
K111145 |
Device Name |
ENDO HEAD |
Applicant |
MEDACTA INTERNATIONAL |
4725 Calle Quetzal, Unit B |
Camarillo,
CA
93012
|
|
Applicant Contact |
ADAM GROSS |
Correspondent |
MEDACTA INTERNATIONAL |
4725 Calle Quetzal, Unit B |
Camarillo,
CA
93012
|
|
Correspondent 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
|
|
|