Device Classification Name |
prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive
|
510(k) Number |
K103756 |
Device Name |
DEPUY ATTUNE TOTAL KNEE SYSTEM |
Applicant |
DEPUY ORTHOPAEDICS, INC. |
700 ORTHOPAEDIC DRIVE |
WARSAW,
IN
46581 -0988
|
|
Applicant Contact |
NANCY FRIDDLE |
Correspondent |
DEPUY ORTHOPAEDICS, INC. |
700 ORTHOPAEDIC DRIVE |
WARSAW,
IN
46581 -0988
|
|
Correspondent Contact |
NANCY FRIDDLE |
Regulation Number | 888.3560
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 12/23/2010 |
Decision Date | 03/15/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|