Device Classification Name |
Prosthesis, Elbow, Constrained, Cemented
|
510(k) Number |
K040389 |
FOIA Releasable 510(k) |
K040389
|
Device Name |
COONRAD/MORREY ELBOW CEMENT RESTRICTOR |
Applicant |
ZIMMER, INC. |
P.O. BOX 708 |
WARSAW,
IN
46581 -0708
|
|
Applicant Contact |
NOAH J BARTSCH |
Correspondent |
ZIMMER, INC. |
P.O. BOX 708 |
WARSAW,
IN
46581 -0708
|
|
Correspondent Contact |
NOAH J BARTSCH |
Regulation Number | 888.3150
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 02/17/2004 |
Decision Date | 05/17/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|