Device Classification Name |
prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer
|
510(k) Number |
K894403 |
Device Name |
PCA MODULAR KNEE CONSTRAINED TIBIAL INSERT |
Applicant |
HOWMEDICA CORP. |
359 VETERANS BLVD. |
RUTHERFORD,
NJ
07070
|
|
Applicant Contact |
ROBERT E SMITH |
Correspondent |
HOWMEDICA CORP. |
359 VETERANS BLVD. |
RUTHERFORD,
NJ
07070
|
|
Correspondent Contact |
ROBERT E SMITH |
Regulation Number | 888.3560
|
Classification Product Code |
|
Date Received | 07/17/1989 |
Decision Date | 02/02/1990 |
Decision |
SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS
(SN) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|