INION CPS 2.5/2.8 SCREW


Device Classification Name

screw, fixation, bone

510(k) Number K022981
Device Name INION CPS 2.5/2.8 SCREW
Original Applicant
INION LTD.
laakarinkatu 2
tampere, 

FI

fin-33520

Original Contact hanna marttila
Regulation Number 888.3040
Classification Product Code
HWC  
Subsequent Product Code
JEY  
Date Received 09/09/2002
Decision Date 09/12/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Dental

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No