510(k) K050227

THREVO SUTURE ANCHOR WITH DISPOSABLE DRIVER by Linvatec Corp. — Product Code MBI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 2, 2005
Date Received
February 1, 2005
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fastener, Fixation, Nondegradable, Soft Tissue
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type