Device Classification Name |
prosthesis, ankle, semi-constrained, cemented, metal/polymer
|
510(k) Number |
K122395 |
Device Name |
DEPUY AGILITY LP TOTAL ANKLE PROSTHESIS |
Applicant |
DEPUY ORTHOPAEDICS, INC. |
700 ORTHOPAEDIC DRIVE |
WARSAW,
IN
46581 -0988
|
|
Applicant Contact |
MEGAN BURNS |
Correspondent |
DEPUY ORTHOPAEDICS, INC. |
700 ORTHOPAEDIC DRIVE |
WARSAW,
IN
46581 -0988
|
|
Correspondent Contact |
MEGAN BURNS |
Regulation Number | 888.3110
|
Classification Product Code |
|
Date Received | 08/07/2012 |
Decision Date | 10/31/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|