Device Classification Name |
prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer
|
510(k) Number |
K884398 |
Device Name |
OMNIFIT TOTAL KNEE SERIES II TIBIAL INSERTS |
Applicant |
OSTEONICS CORP. |
59 ROUTE 17 |
ALLENDALE,
NJ
07401 -1677
|
|
Applicant Contact |
MICHAEL B SHELDON |
Correspondent |
OSTEONICS CORP. |
59 ROUTE 17 |
ALLENDALE,
NJ
07401 -1677
|
|
Correspondent Contact |
MICHAEL B SHELDON |
Regulation Number | 888.3560
|
Classification Product Code |
|
Date Received | 10/19/1988 |
Decision Date | 01/17/1989 |
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
|
|
|