Device Classification Name |
Shoulder Prosthesis, Reverse Configuration
|
510(k) Number |
K122442 |
Device Name |
DEPUY CTA REVERSE SHOULDER SYSTEM |
Applicant |
DEPUY FRANCE |
700 ORTHOPAEDIC DRIVE |
WARSAW,
IN
46580
|
|
Applicant Contact |
MEGAN BURNS |
Correspondent |
DEPUY FRANCE |
700 ORTHOPAEDIC DRIVE |
WARSAW,
IN
46580
|
|
Correspondent Contact |
MEGAN BURNS |
Regulation Number | 888.3660
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 08/10/2012 |
Decision Date | 09/06/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|