Device Classification Name |
prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer
|
510(k) Number |
K910990 |
Device Name |
OSTEONICS 7000 SERIES TOTAL KNEE TIBIAL COMPONENTS |
Applicant |
OSTEONICS CORP. |
59 ROUTE 17 |
ALLENDALE,
NJ
07401 -1677
|
|
Applicant Contact |
PAT KRAMER |
Correspondent |
OSTEONICS CORP. |
59 ROUTE 17 |
ALLENDALE,
NJ
07401 -1677
|
|
Correspondent Contact |
PAT KRAMER |
Regulation Number | 888.3560
|
Classification Product Code |
|
Date Received | 03/07/1991 |
Decision Date | 06/19/1991 |
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
|
|
|