TORNIER INSITE FT BIOCOMPOSITE SUTURE ANCHOR


Device Classification Name

fastener, fixation, biodegradable, soft tissue

510(k) Number K122635
Device Name TORNIER INSITE FT BIOCOMPOSITE SUTURE ANCHOR
Applicant
TORNIER, INC.
10801 nesbitt avenue
bloomington, 
MN 
55437

Applicant Contact lael j pickett
Correspondent
TORNIER, INC.
10801 nesbitt avenue
bloomington, 
MN 
55437

Correspodent Contact lael j pickett
Regulation Number 888.3030
Classification Product Code
MAI  
Subsequent Product Code
HWC  
Date Received 08/29/2012
Decision Date 05/13/2013
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No