Device Classification Name |
prosthesis, knee, femorotibial, semi-constrained, cemented, metal/polymer
|
510(k) Number |
K983657 |
Device Name |
OSTEONICS SERIES 7000 AD TIBIAL TRAY |
Applicant |
OSTEONICS CORP. |
59 ROUTE 17 |
ALLENDALE,
NJ
07401 -1677
|
|
Applicant Contact |
ELIZABETH A STAUB |
Correspondent |
OSTEONICS CORP. |
59 ROUTE 17 |
ALLENDALE,
NJ
07401 -1677
|
|
Correspondent Contact |
ELIZABETH A STAUB |
Regulation Number | 888.3530
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 10/19/1998 |
Decision Date | 04/06/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|