Device Classification Name |
Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
|
510(k) Number |
K862632 |
Device Name |
INSALL/BURSTEIN(TM)* II TIBIAL WEDGES |
Applicant |
ZIMMER, INC. |
P.O. BOX 708 |
WARSAW,
IN
46581 -0708
|
|
Applicant Contact |
MAX SHERMAN |
Correspondent |
ZIMMER, INC. |
P.O. BOX 708 |
WARSAW,
IN
46581 -0708
|
|
Correspondent Contact |
MAX SHERMAN |
Regulation Number | 888.3520
|
Classification Product Code |
|
Date Received | 07/10/1986 |
Decision Date | 03/25/1987 |
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
|
|
|