Device Classification Name |
Screw, Fixation, Bone
|
510(k) Number |
K972494 |
Device Name |
DEPUY DUPONT ABSORBABLE SET SCREW |
Applicant |
DEPUY, INC. |
700 ORTHOPAEDIC DR. |
P.O. BOX 988 |
WARSAW,
IN
46581 -0988
|
|
Applicant Contact |
SALLY FOUST |
Correspondent |
DEPUY, INC. |
700 ORTHOPAEDIC DR. |
P.O. BOX 988 |
WARSAW,
IN
46581 -0988
|
|
Correspondent Contact |
SALLY FOUST |
Regulation Number | 888.3040 |
Classification Product Code |
|
Date Received | 07/03/1997 |
Decision Date | 10/01/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|