TORNIER CINCH KNOTLESS FIXATION IMPLANT SYSTEM


Device Classification Name

fastener, fixation, nondegradable, soft tissue

510(k) Number K080335
Device Name TORNIER CINCH KNOTLESS FIXATION IMPLANT SYSTEM
Applicant
TORNIER, INC.
100 cummings center
suite 444c
beverly, 
MA 
01915

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

Correspodent Contact howard schrayer
Regulation Number 888.3040
Classification Product Code
MBI  
Date Received 02/07/2008
Decision Date 04/23/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No