Device Classification Name |
screw, fixation, bone
|
510(k) Number |
K012872 |
Device Name |
RESORBABLE SCREW ANCHOR |
Applicant |
ARTHROTEK, INC. |
56 EAST BELLE DR. |
P.O. BOX 587 |
WARSAW,
IN
46582
|
|
Applicant Contact |
SARA B SHULTZ |
Correspondent |
ARTHROTEK, INC. |
56 EAST BELLE DR. |
P.O. BOX 587 |
WARSAW,
IN
46582
|
|
Correspondent Contact |
SARA B SHULTZ |
Regulation Number | 888.3040
|
Classification Product Code |
|
Date Received | 08/27/2001 |
Decision Date | 11/20/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|