Device Classification Name |
prosthesis, shoulder, hemi-, humeral, metallic uncemented
|
510(k) Number |
K010827 |
Device Name |
COPELAND MB/HA RESURFACING HUMERAL HEADS |
Applicant |
BIOMET ORTHOPEDICS, INC. |
P.O. BOX 587 |
WARSAW,
IN
46581 -0587
|
|
Applicant Contact |
SARA A BAILEY |
Correspondent |
BIOMET ORTHOPEDICS, INC. |
P.O. BOX 587 |
WARSAW,
IN
46581 -0587
|
|
Correspondent Contact |
SARA A BAILEY |
Regulation Number | 888.3690
|
Classification Product Code |
|
Date Received | 03/20/2001 |
Decision Date | 09/14/2001 |
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
|
|
|