Device Classification Name |
Screw, Fixation, Bone
|
510(k) Number |
K080088 |
Device Name |
BIOMET SPORTS MEDICINE ANCHOR DEVICES AND ZIPLOOP CONSTRUCTS |
Applicant |
BIOMET MANUFACTURING, INC. |
56 EAST BELL DR. |
WARSAW,
IN
46581 -0587
|
|
Applicant Contact |
ROBERT R FRIDDLE |
Correspondent |
BIOMET MANUFACTURING, INC. |
56 EAST BELL DR. |
WARSAW,
IN
46581 -0587
|
|
Correspondent Contact |
ROBERT R FRIDDLE |
Regulation Number | 888.3040
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 01/14/2008 |
Decision Date | 06/11/2008 |
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
|
|
|