Device Classification Name |
appliance, fixation, nail/blade/plate combination, multiple component
|
510(k) Number |
K003397 |
Device Name |
COLLES C SERIES FRAME STERILE PACK |
Applicant |
DEPUY ORTHOPAEDICS, INC. |
700 ORTHOPAEDIC DRIVE |
WARSAW,
IN
46581 -0988
|
|
Applicant Contact |
MARCIA J ARENTZ |
Correspondent |
DEPUY ORTHOPAEDICS, INC. |
700 ORTHOPAEDIC DRIVE |
WARSAW,
IN
46581 -0988
|
|
Correspondent Contact |
MARCIA J ARENTZ |
Regulation Number | 888.3030
|
Classification Product Code |
|
Date Received | 11/01/2000 |
Decision Date | 01/29/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|