BIORETEC ACTIVASCREW, ACTIVASCREW CANNULATED AND ACTIVASCREW CANNULATED WITH ACTIVAPIN


Device Classification Name

screw, fixation, bone

510(k) Number K081392
Device Name BIORETEC ACTIVASCREW, ACTIVASCREW CANNULATED AND ACTIVASCREW CANNULATED WITH ACTIVAPIN
Applicant
BIORETEC LTD
hermiankatu 22 modulight bldg
tampere, 

FI

fi-33720

Applicant Contact mari ruotsalainen
Correspondent
BIORETEC LTD
hermiankatu 22 modulight bldg
tampere, 

FI

fi-33720

Correspodent Contact mari ruotsalainen
Regulation Number 888.3040
Classification Product Code
HWC  
Date Received 05/19/2008
Decision Date 06/18/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No