Device Classification Name |
prosthesis, hip, semi-constrained, metal/polymer, cemented
|
510(k) Number |
K072857 |
Device Name |
TOTAL HIP PROSTHESIS SYSTEM QUADRA S + COCRMO FEMORAL BALL HEAD + APRICOT |
Applicant |
MEDACTA INTERNATIONAL, SA |
18 BIRDIE LANE |
NORFOLK,
MA
02056
|
|
Applicant Contact |
PAMELA J WEAGRAFF |
Correspondent |
MEDACTA INTERNATIONAL, SA |
18 BIRDIE LANE |
NORFOLK,
MA
02056
|
|
Correspondent Contact |
PAMELA J WEAGRAFF |
Regulation Number | 888.3350
|
Classification Product Code |
|
Date Received | 10/05/2007 |
Decision Date | 02/04/2008 |
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
|
|
|