TRIGEN LOW PROFILE BONE SCREW


Device Classification Name

rod, fixation, intramedullary and accessories

510(k) Number K111025
Device Name TRIGEN LOW PROFILE BONE SCREW
Applicant
SMITH & NEPHEW, INC.
7135 goodlett farms parkway
cordova, 
TN 
38016

Applicant Contact natalie p williams
Correspondent
SMITH & NEPHEW, INC.
7135 goodlett farms parkway
cordova, 
TN 
38016

Correspodent Contact natalie p williams
Regulation Number 888.3020
Classification Product Code
HSB  
Date Received 04/13/2011
Decision Date 07/01/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls