Device Classification Name |
Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
|
510(k) Number |
K810520 |
Device Name |
INSALL/BURSTEIN CONSTRAINED TOTAL CONDYL |
Applicant |
ZIMMER, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
ZIMMER, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 888.3510
|
Classification Product Code |
|
Date Received | 02/26/1981 |
Decision Date | 03/26/1981 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|