ACTIVATM PRODUCT GROUP INCLUDING BIOABSORBABLE DEVICES ACTIVAPIN FUSION, ACTIVANAILTM CONICALTM


Device Classification Name

pin, fixation, smooth

510(k) Number K080879
Device Name ACTIVATM PRODUCT GROUP INCLUDING BIOABSORBABLE DEVICES ACTIVAPIN FUSION, ACTIVANAILTM CONICALTM
Applicant
BIORETEC LTD
hermiakatu 22 modulight bldg
tampere, 

FI

fi-33720

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

FI

fi-33720

Correspodent Contact mari ruotsalainen
Regulation Number 888.3040
Classification Product Code
HTY  
Date Received 03/31/2008
Decision Date 06/24/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No