Device Classification Name |
plate, fixation, bone
|
510(k) Number |
K101421 |
Device Name |
MEDICAL PLATES, LATERAL PLATES, POSTERIOR LATERAL PLATES, OLECRANON PLATES MODEL 131218704-708; 851318704-708, 131218204 |
Applicant |
DEPUY ORTHOPAEDICS, INC. |
700 ORTHOPAEDIC DRIVE |
WARSAW,
IN
46581 -0988
|
|
Applicant Contact |
SUZANA OTANO |
Correspondent |
DEPUY ORTHOPAEDICS, INC. |
700 ORTHOPAEDIC DRIVE |
WARSAW,
IN
46581 -0988
|
|
Correspondent Contact |
SUZANA OTANO |
Regulation Number | 888.3030
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 05/20/2010 |
Decision Date | 06/15/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|