Device Classification Name |
prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer
|
510(k) Number |
K060192 |
Device Name |
APEX KNEE SYSTEM |
Applicant |
OMNI LIFE SCIENCE, INC. |
175 PARAMOUNT DRIVE |
SUITE 302 |
RAYNHAM,
MA
02767
|
|
Applicant Contact |
EDWARD J CHEAL |
Correspondent |
OMNI LIFE SCIENCE, INC. |
175 PARAMOUNT DRIVE |
SUITE 302 |
RAYNHAM,
MA
02767
|
|
Correspondent Contact |
EDWARD J CHEAL |
Regulation Number | 888.3560
|
Classification Product Code |
|
Date Received | 01/25/2006 |
Decision Date | 06/15/2006 |
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
|
|
|