Device Classification Name |
screw, fixation, bone
|
510(k) Number |
K021832 |
Device Name |
ARTHROTEK RESORBABLE NO-PROFILE LACTOSORB L-15 SCREW & WASHER |
Applicant |
BIOMET, INC. |
56 EAST BELL DR. |
PO BOX 587 |
WARSAW,
IN
46581 -0587
|
|
Applicant Contact |
SARA B SHULTZ |
Correspondent |
BIOMET, INC. |
56 EAST BELL DR. |
PO BOX 587 |
WARSAW,
IN
46581 -0587
|
|
Correspondent Contact |
SARA B SHULTZ |
Regulation Number | 888.3040
|
Classification Product Code |
|
Date Received | 06/04/2002 |
Decision Date | 06/26/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|