Device Classification Name |
Plate, Fixation, Bone
|
510(k) Number |
K982483 |
Device Name |
DEPUY MOTECH PEAK FIXATION SYSTEM |
Applicant |
DEPUY ORTHOPAEDICS, INC. |
700 ORTHOPAEDIC DRIVE |
WARSAW,
IN
46581 -0988
|
|
Applicant Contact |
ARLENE C SAULL |
Correspondent |
DEPUY ORTHOPAEDICS, INC. |
700 ORTHOPAEDIC DRIVE |
WARSAW,
IN
46581 -0988
|
|
Correspondent Contact |
ARLENE C SAULL |
Regulation Number | 888.3030
|
Classification Product Code |
|
Date Received | 07/17/1998 |
Decision Date | 09/14/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|