510(k) K061389

ALLTHREAD LACTOSORB SUTURE ANCHOR by Arthrotek, Inc. — Product Code JDR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 19, 2006
Date Received
May 18, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Staple, Fixation, Bone
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type