REPROCESSED EXTERNAL FIXATION ACCESSORIES


Device Classification Name

appliance, fixation, nail/blade/plate combination, multiple component

510(k) Number K081342
Device Name REPROCESSED EXTERNAL FIXATION ACCESSORIES
Applicant
STERILMED, INC.
11400 73rd ave. north
maple grove, 
MN 
55369

Applicant Contact joshua clarin
Correspondent
STERILMED, INC.
11400 73rd ave. north
maple grove, 
MN 
55369

Correspodent Contact joshua clarin
Regulation Number 888.3030
Classification Product Code
KTT  
Date Received 05/13/2008
Decision Date 08/13/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No