Device Classification Name |
prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer
|
510(k) Number |
K972863 |
Device Name |
DURATION STABILIZED UHMWPE KNEE COMPONENTS |
Applicant |
HOWMEDICA CORP. |
359 VETERANS BLVD. |
RUTHERFORD,
NJ
07070
|
|
Applicant Contact |
FRANK MAAS |
Correspondent |
HOWMEDICA CORP. |
359 VETERANS BLVD. |
RUTHERFORD,
NJ
07070
|
|
Correspondent Contact |
FRANK MAAS |
Regulation Number | 888.3560
|
Classification Product Code |
|
Date Received | 08/04/1997 |
Decision Date | 10/29/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|