510(k) K053561

BIO-MINI REVO SUTURE ANCHOR by Conmed Linvatec — Product Code HWC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 23, 2006
Date Received
December 21, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Screw, Fixation, Bone
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type