Device Classification Name |
prosthesis, knee, femorotibial, semi-constrained, cemented, metal/polymer
|
510(k) Number |
K820030 |
Device Name |
HOWMEDICA KINEMATIC TOTAL CONDYLAR KNEE |
Applicant |
HOWMEDICA CORP. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Correspondent |
HOWMEDICA CORP. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Regulation Number | 888.3530
|
Classification Product Code |
|
Date Received | 01/05/1982 |
Decision Date | 02/05/1982 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|