Device Classification Name |
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
|
510(k) Number |
K023453 |
Device Name |
DEPUY SUMMIT FX CEMENTED HIP PROSTHESIS |
Applicant |
DEPUY ORTHOPAEDICS, INC. |
700 ORTHOPAEDIC DRIVE |
WARSAW,
IN
46581 -0988
|
|
Applicant Contact |
CHERYL HASTINGS |
Correspondent |
DEPUY ORTHOPAEDICS, INC. |
700 ORTHOPAEDIC DRIVE |
WARSAW,
IN
46581 -0988
|
|
Correspondent Contact |
CHERYL HASTINGS |
Regulation Number | 888.3350
|
Classification Product Code |
|
Date Received | 10/15/2002 |
Decision Date | 11/13/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|