Device Classification Name |
Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
|
510(k) Number |
K023063 |
Device Name |
COMPREHENSIVE HUMERAL FRACTURE SYSTEM |
Applicant |
BIOMET ORTHOPEDICS, INC. |
P.O. BOX 587 |
WARSAW,
IN
46581 -0587
|
|
Applicant Contact |
DALENE T BINKLEY |
Correspondent |
BIOMET ORTHOPEDICS, INC. |
P.O. BOX 587 |
WARSAW,
IN
46581 -0587
|
|
Correspondent Contact |
DALENE T BINKLEY |
Regulation Number | 888.3650
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 09/16/2002 |
Decision Date | 12/13/2002 |
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
|
|
|