Device Classification Name |
prosthesis, shoulder, non-constrained, metal/polymer cemented
|
510(k) Number |
K915596 |
Device Name |
BIOMODULAR SHOULDER HUMERAL HEAD W/ IONGUARD |
Applicant |
BIOMET, INC. |
P.O. BOX 587 |
AIRPORT INDUSTRIAL PARK |
WARSAW,
IN
46581 -0587
|
|
Applicant Contact |
PATRICIA BERES |
Correspondent |
BIOMET, INC. |
P.O. BOX 587 |
AIRPORT INDUSTRIAL PARK |
WARSAW,
IN
46581 -0587
|
|
Correspondent Contact |
PATRICIA BERES |
Regulation Number | 888.3650
|
Classification Product Code |
|
Date Received | 12/13/1991 |
Decision Date | 03/11/1992 |
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
|
|
|