Device Classification Name |
prosthesis, hip, semi-constrained, metal/polymer, uncemented
|
510(k) Number |
K030122 |
Device Name |
DEPUY SUMMIT BASIC PRESS-FIT HIP STEM |
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 | 888.3360
|
Classification Product Code |
|
Date Received | 01/14/2003 |
Decision Date | 02/05/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|