Device Classification Name |
appliance, fixation, nail/blade/plate combination, multiple component
|
510(k) Number |
K013503 |
Device Name |
MODIFICATION TO: STERILE COLLES CLASSIC FIXATOR |
Applicant |
DEPUY ORTHOPAEDICS, INC. |
700 ORTHOPAEDIC DR. |
WARSAW,
IN
46581 -0988
|
|
Applicant Contact |
MARCIA J ARENTZ |
Correspondent |
DEPUY ORTHOPAEDICS, INC. |
700 ORTHOPAEDIC DR. |
WARSAW,
IN
46581 -0988
|
|
Correspondent Contact |
MARCIA J ARENTZ |
Regulation Number | 888.3030
|
Classification Product Code |
|
Date Received | 10/22/2001 |
Decision Date | 11/16/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|