Device Classification Name |
Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
|
510(k) Number |
K062426 |
FOIA Releasable 510(k) |
K062426
|
Device Name |
DEPUY PINNACLE METAL-ON-METAL ACETABULAR CUP LINERS |
Applicant |
DEPUY ORTHOPAEDICS, INC. |
700 ORTHOPAEDIC DR. |
P.O BOX 988 |
WARSAW,
IN
46581 -0988
|
|
Applicant Contact |
ANNE M SCHULER |
Correspondent |
DEPUY ORTHOPAEDICS, INC. |
700 ORTHOPAEDIC DR. |
P.O BOX 988 |
WARSAW,
IN
46581 -0988
|
|
Correspondent Contact |
ANNE M SCHULER |
Regulation Number | 888.3330
|
Classification Product Code |
|
Date Received | 08/18/2006 |
Decision Date | 12/15/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|