TORNIER INSITE FT SUTURE ANCHOR


Device Classification Name

fastener, fixation, nondegradable, soft tissue

510(k) Number K110773
Device Name TORNIER INSITE FT SUTURE ANCHOR
Applicant
TORNIER, INC.
100 cummings center,
suite 444c
beverly, 
MA 
01915

Applicant Contact brahim hadri
Correspondent
TORNIER, INC.
100 cummings center,
suite 444c
beverly, 
MA 
01915

Correspodent Contact brahim hadri
Regulation Number 888.3040
Classification Product Code
MBI  
Date Received 03/21/2011
Decision Date 06/02/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No