510(k) K041064

BIOKNOTLESS RC ANCHOR by Depuy Mitek — Product Code JDR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 13, 2004
Date Received
April 23, 2004
Clearance Type
Special
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