Device Classification Name |
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
|
510(k) Number |
K093944 |
Device Name |
MEDACTA TOTAL HIP PROTHESIS SYSTEM-AMISTEN H , QUADRA H, QUADRA S |
Applicant |
MEDACTA INTERNATIONAL, SA |
4725 CALLE QUETZAL SUITE B |
CAMARILLO,
CA
93012
|
|
Applicant Contact |
HEATHER NEELY |
Correspondent |
MEDACTA INTERNATIONAL, SA |
4725 CALLE QUETZAL SUITE B |
CAMARILLO,
CA
93012
|
|
Correspondent Contact |
HEATHER NEELY |
Regulation Number | 888.3353
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 12/22/2009 |
Decision Date | 01/21/2010 |
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
|
|
|