Device Classification Name |
prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
|
510(k) Number |
K953925 |
Device Name |
FINE GRAIN CAST COBALT CHROMIUM HIP STEMS |
Applicant |
BIOMET, INC. |
AIRPORT INDUSTRIAL PARK |
WARSAW,
IN
46581
|
|
Applicant Contact |
LISANA W MANN |
Correspondent |
BIOMET, INC. |
AIRPORT INDUSTRIAL PARK |
WARSAW,
IN
46581
|
|
Correspondent Contact |
LISANA W MANN |
Regulation Number | 888.3353
|
Classification Product Code |
|
Date Received | 08/18/1995 |
Decision Date | 01/31/1996 |
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
|
|
|