Device Classification Name |
prosthesis, knee, femorotibial, non-constrained, cemented, metal/polymer
|
510(k) Number |
K010685 |
Device Name |
MODIFICATION TO MILLER/GALANTE PRECOAT UNICOMPARTMENTAL KNEE SYSTEM (8 MM ARTICULAR SURFACE) |
Applicant |
ZIMMER, INC. |
P.O. BOX 708 |
WARSAW,
IN
46581 -0708
|
|
Applicant Contact |
STEPHEN H MCKELVEY |
Correspondent |
ZIMMER, INC. |
P.O. BOX 708 |
WARSAW,
IN
46581 -0708
|
|
Correspondent Contact |
STEPHEN H MCKELVEY |
Regulation Number | 888.3520
|
Classification Product Code |
|
Date Received | 03/08/2001 |
Decision Date | 04/02/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|