Device Classification Name |
prosthesis, hip, constrained, cemented or uncemented, metal/polymer
|
510(k) Number |
K071059 |
Device Name |
DEPUY SPA POROUS COATED PROXIMAL SLEEVE |
Applicant |
DEPUY ORTHOPAEDICS, INC. |
P.O. BOX 988 |
WARSAW,
IN
46581 -0988
|
|
Applicant Contact |
KATHY HARRIS |
Correspondent |
DEPUY ORTHOPAEDICS, INC. |
P.O. BOX 988 |
WARSAW,
IN
46581 -0988
|
|
Correspondent Contact |
KATHY HARRIS |
Regulation Number | 888.3310
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 04/16/2007 |
Decision Date | 11/09/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|