Device Classification Name |
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
|
510(k) Number |
K083116 |
Device Name |
VERSAFIT CUP DOUBLE MOBILITY SYSTEM |
Applicant |
MEDACTA INTERNATIONAL, SA |
13721 VIA TRES VISTA |
SAN DIEGO,
CA
92129
|
|
Applicant Contact |
NATALIE J KENNEL |
Correspondent |
MEDACTA INTERNATIONAL, SA |
13721 VIA TRES VISTA |
SAN DIEGO,
CA
92129
|
|
Correspondent Contact |
NATALIE J KENNEL |
Regulation Number | 888.3353
|
Classification Product Code |
|
Date Received | 10/21/2008 |
Decision Date | 04/07/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|