TORNIER COLLAGEN COATED BIOFIBER SCAFFOLD


Device Classification Name

mesh, surgical, polymeric

510(k) Number K111337
Device Name TORNIER COLLAGEN COATED BIOFIBER SCAFFOLD
Applicant
TORNIER, INC.
7701 france ave south
suite 600
edina, 
MN 
55435

Applicant Contact howard l schrayer
Correspondent
TORNIER, INC.
7701 france ave south
suite 600
edina, 
MN 
55435

Correspodent Contact howard l schrayer
Regulation Number 878.3300
Classification Product Code
FTL  
Date Received 05/12/2011
Decision Date 01/25/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No