Device Classification Name |
staple, fixation, bone
|
510(k) Number |
K061801 |
Device Name |
2.8 & 3.5MM LACTOSCREW SUTURE ANCHORS |
Applicant |
ARTHROTEK, INC. |
56 EAST BELL DR. |
P.O. BOX 587 |
WARSAW,
IN
46581 -0587
|
|
Applicant Contact |
SUSAN ALEXANDER |
Correspondent |
ARTHROTEK, INC. |
56 EAST BELL DR. |
P.O. BOX 587 |
WARSAW,
IN
46581 -0587
|
|
Correspondent Contact |
SUSAN ALEXANDER |
Regulation Number | 888.3030
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 06/26/2006 |
Decision Date | 08/07/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|