Device Classification Name |
prosthesis, knee, femorotibial, semi-constrained, cemented, metal/polymer
|
510(k) Number |
K070267 |
Device Name |
DEPUY GCK TIBIAL COMPONENTS |
Applicant |
DEPUY ORTHOPAEDICS, INC. |
700 ORTHOPAEDIC DR. |
WARSAW,
IN
46582
|
|
Applicant Contact |
NANCY FRIDDLE |
Correspondent |
DEPUY ORTHOPAEDICS, INC. |
700 ORTHOPAEDIC DR. |
WARSAW,
IN
46582
|
|
Correspondent Contact |
NANCY FRIDDLE |
Regulation Number | 888.3530
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 01/29/2007 |
Decision Date | 08/17/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|