Device Classification Name |
nail, fixation, bone
|
510(k) Number |
K800144 |
Device Name |
FEMORAL CEMENT RESTRICTOR |
Applicant |
BIOMET, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
BIOMET, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 888.3030
|
Classification Product Code |
|
Date Received | 01/21/1980 |
Decision Date | 02/19/1980 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|