Device Classification Name |
prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
|
510(k) Number |
K991990 |
Device Name |
TRI-POLAR SYSTEM |
Applicant |
BIOMET, INC. |
AIRPORT INDUSTRIAL PARK, |
P.O.BOX 587 |
WARSAW,
IN
46581 -0587
|
|
Applicant Contact |
MICHELLE L MCKINLEY |
Correspondent |
BIOMET, INC. |
AIRPORT INDUSTRIAL PARK, |
P.O.BOX 587 |
WARSAW,
IN
46581 -0587
|
|
Correspondent Contact |
MICHELLE L MCKINLEY |
Regulation Number | 888.3390
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 06/14/1999 |
Decision Date | 09/10/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|