Device Classification Name |
prosthesis, hip, semi-constrained, metal/polymer, porous uncemented
|
510(k) Number |
K132959 |
Device Name |
DEPUY PINNACLE ALTRX ACETABULAR LINERS |
Applicant |
DEPUY ORTHOPAEDICS, INC. |
700 ORTHOPAEDIC DR. |
WARSAW,
IN
46582
|
|
Applicant Contact |
MEGAN BURNS |
Correspondent |
DEPUY ORTHOPAEDICS, INC. |
700 ORTHOPAEDIC DR. |
WARSAW,
IN
46582
|
|
Correspondent Contact |
MEGAN BURNS |
Regulation Number | 888.3358
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 09/20/2013 |
Decision Date | 03/10/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|